Accu-Chek 08453071001 Urgent Medical Device Removal User Manual

Accu-Chek 08453071001 Urgent Medical Device Removal

Product Information

• Specifications:
  • Measurement Unit: mmol/L
  • Product REF Number: 08453071001
  • Product Device Identifier (UDI/GTIN): 00365702729100
  • Product Lot Numbers: 207482, 207519, 207526, 207545, 207454

Product Usage Instructions

• The Accu-Chek Guide blood glucose meters with the affected serial numbers listed above have been configured incorrectly. To ensure accurate results and avoid potential health risks, please follow these steps:
  • Stop Usage: If you have a meter with one ofthe affected serial numbers, discontinue its use immediately.
  • Contact Customer Care: Contact Accu-ChekCustomer Care at 1-800-858-8072 to arrange for the return and replacement of the device.
  • Verify Serial Number: Check if your meter serial number matches any of the listed affected serial numbers provided in the manual.

FAQs

• Q: Why is it important to discontinue the use of the affected meters?
  • A: The misconfiguration may lead to incorrect results, potentially causing customers to misinterpret their blood glucose levels and make inappropriate treatment decisions.
• Q: How can I identify if my meter is affected?
  • A: Check the serial number of your meter against the list of affected serial numbers provided in the manual.
• Q: What should I do if my meter is one of the affected devices?
  • A: Immediately stop using the meter and contact Accu-Chek Customer Care at 1-800-858-8072 to arrange for a return and replacement.

Accu-Chek® Guide system: Meters showing incorrect measurement unit (mmol/L rather than mg/dL)

Urgent Medical Device Removal

This Urgent Medical Device Removal (UMDR) only applies to the following products:

Affected Meter Serial Number| Product Description| Product REF

Number

| Product Device Identifier (UDI / GTIN)| Product Lot Number
---|---|---|---|---
92339920445| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207482
92339955415| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207482
92340116052| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207519
92340117408| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207519
92340120006| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207519
92340120057| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207519
92339920116| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207526
92339094787| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207545
92339744998| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207454

Issue:

• Roche Diabetes Care has received three customer complaints, including one US complaint, in which the meter was reading in the incorrect unit of measure.
• The complaints were reported to the FDA as quality issues via the Medical Device Reporting program.
• The resulting Roche complaint investigations indicated that the above Accu-Chek Guide systems were configured incorrectly, and thus show the results in mmol/L rather than in the labeled measuring unit, mg/dL.
• It becomes visible once a blood glucose measurement is taken and the user can recognize that the result is displayed as mmol/L rather than mg/dL.
• Roche Diabetes Care has conducted an in-depth evaluation of the underlying root cause of the above-described issue and has corrected the issue to prevent recurrence.

Risk to Health:

• This misconfiguration may result in customers perceiving wrong units of measure, and/or interpreting a result as approximately 18 times lower than the actual blood glucose.
• In the worst case, these misleading displayed results, in the wrong unit of measure, may trigger an inappropriate treatment decision (consumption of carbohydrates) with potentially severe consequences.

Reason for the Notification:

• Investigations have revealed that the nine meters listed above were configured incorrectly and thus show the results in a different than labelled measuring unit.
• This notification is to inform customers of the issue and to instruct customers to discontinue the use of the Accu-Chek Guide blood glucose meters with the serial numbers listed above and contact Accu-Chek Customer Care at 1-800-858- 8072 to arrange for return and replacement.

Actions Required by End Users

• We ask all users of the Accu-Chek Guide blood glucose monitoring system to Please check your meter to see if the display shows the appropriate measuring unit (mg/dL)
• Please compare the serial number of your meter with the listed affected serial numbers to determine if it is impacted by this issue. Please see the affected serial numbers below.
  92339920445| 92340117408| 92339920116
  ---|---|---
  92339955415| 92340120006| 92339094787
  92340116052| 92340120057| 92339744998
• Please stop using your Accu-Chek Guide meter if you notice that your product shows an incorrect measuring unit or the serial number is one of the listed impacted products and:
• Please visit http://accu-chek.com/notices/UMDR-24-001 and enter your serial number. The form will provide instructions on how to proceed. Otherwise, you may contact our Roche Diabetes Care Accu-Chek Customer Care line at 1-800-858-8072 (Monday – Friday from 8:00 a.m. ET – 8:00 p.m. ET).
• Please keep this UMDR for future reference.

Actions Required for Distributors/Retailers

• Read this UMDR (24-001).
• Please check the meters remaining in your stock for the impacted serial number.

Affected Meter Serial Number| Product Description| Product REF Number| Product Device Identifier (UDI / GTIN)| Product Lot Number
---|---|---|---|---
92339920445| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207482
92339955415| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207482
92340116052| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207519
92340117408| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207519
92340120006| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207519
92340120057| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207519
92339920116| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207526
92339094787| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207545
92339744998| Accu-Chek® Guide (SC) Kit| 08453071001| 00365702729100| 207454

If you identify an Accu-Chek Guide blood glucose meter with one of the serial numbers noted above, remove it from your inventory and contact our Roche Diabetes Care Accu-Chek Customer Care line at 1-800-858-8072 (Monday – Friday from 8:00 a.m. ET – 8:00 p.m. ET) to arrange for return and replacement.

• If you have distributed the products noted above to other suppliers, provide a copy of this UMDR to those suppliers to whom you have shipped products from the above-listed Product Lot Numbers.
• If you have distributed products of the lots noted above to consumer customers, make the UMDR available to those customers.
• Complete all sections of the enclosed distributor faxback form (24-001) and fax or email it according to the instructions on the form.
• Contact your Roche Account Manager or your distributor if you have questions regarding the information in this UMDR.
• Please keep this UMDR for future reference.

For questions regarding this UMDR or other questions related to your Roche Diabetes Care products, please contact your Roche Account Manager or contact Accu-Chek Customer Care at 1-800-858-8072.

• ACCU-CHEK GUIDE and ROCHE DIABETES CARE are trademarks of Roche. ART-10333570001
• This notification is being made with the knowledge of the Food and Drug Administration (FDA).
• You may also report adverse events or quality problems experienced with the use of this product to the FDA’s
• MedWatch Adverse Events Reporting Program online at www.fda.gov/Safety/MedWatch/HowToReport/default.htm.  (form available to fax or mail), or call the FDA at 1-800-FDA-1088.

References

• UMDR 24-001 | Accu-Chek
• Reporting Serious Problems to FDA | FDA
• UMDR 24-001 | Accu-Chek

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