ACCU-CHEK 406124 Active Complete Kit User Manual
- June 5, 2024
- ACCU-CHEK
Table of Contents
User Manual
406124 Active Complete Kit
Urgent Field Safety Notice
For attention of: Accu-Chek Guide users (PwD)
Manufacturer’s reference: SB_RDC_2024_01
SRN number: DE-MF-000006276
Country – India
Date – 08 May 2024
Important information related to the Accu-Chek® Guide system: Voluntary recall
of meters showing incorrect measurement unit
Dear Accu-Chek Guide user,
At Roche Diabetes Care we strive for the highest quality of our products and
services and are committed to keeping you timely informed on any issue
associated with our products. Today, we would like to notify you of a
voluntary corrective measure that we are initiating concerning our Accu-Chek
Guide blood glucose meter.
We recently received a very low number of customer complaints indicating that
some Accu-Chek Guide systems out of the below-listed lots were congured
incorrectly and thus show the results in a different than labeled measuring
unit.
Description of situation and rationale giving rise to this corrective
measure
Because patient safety is our top priority, we inform you today about the
potential risk resulting from the above-described issue. It becomes visible
once a blood glucose measurement is taken and the user could recognise that
the result is displayed in a different than the usual measuring unit (mg/dL or
mmol/l). If going unnoticed, the incorrectly displayed blood glucose value
might trigger inappropriate therapy decisions including the administration of
insulin and potentially result in severe consequences. Possible consequences
of this issue could range from no clinical impact to adverse health events
including hypoglycemia, hyperglycemia, or diabetic ketoacidosis (DKA).
Details on affected devices:
Affected Meter
Serial Number| Product
Description| Product REF
Number| Product Device
Identier (UDI/GTIN)| Product Lot
Number
---|---|---|---|---
92539453001| Accu-Chek® Guide (SC) Set| 7400926027| 4.01563E+12| 406124
92539646082| Accu-Chek® Guide (SC) Set| 7400926027| 4.01563E+12| 406124
92539453042| Accu-Chek® Guide (SC) Set| 7400926027| 4.01563E+12| 406124
92539658918| Accu-Chek® Guide (SC) Set| 7400926027| 4.01563E+12| 406124
Actions taken by Roche Diabetes Care
We have conducted an in-depth evaluation of the underlying root cause of the
above-described issue and have adapted our manufacturing and quality control
processes to prevent the issue from recurring.
Actions to be performed by Accu-Chek Guide users
We ask all users of the Accu-Chek Guide blood glucose monitoring system to
- please check your meter if the display shows the same measuring unit as the label on the back side of the product or the meter packaging
- please compare the serial number of your meter with the above list to determine if it belongs to the products impacted by this issue
- please stop using your Accu-Chek Guide meter if you notice that your product shows an incorrect measuring unit or belongs to the listed impacted products
- please contact our Roche Diabetes Care Customer Care Toll Free line at 18001206020 (Monday to Saturday from 07:30 a.m.- 09:30 p.m.) Email – india.accu-chek@roche.com or SMS – type HELP and send to 5757535 (Rs. 3/- per SMS) to receive your replacement meter free of charge.
Please be assured that all other Accu-Chek and Accu-Chek Guide meters not
included in this voluntary corrective action are not impacted by this issue
and are safe to be used as intended.
Communication of this Field Safety Notice
Your national competent authority, distributors, retailers, and healthcare
professionals have been informed about this eld action.
We sincerely apologize for any inconvenience this may cause and hope for your
understanding and cooperation. Please contact our Roche Diabetes Care Customer
Care Toll Free line at 18001206020 (Monday to Saturday from 07:30 a.m. – 09:30
p.m.) Email – india.accu-chek@roche.com or
SMS – type HELP and send to 5757535 (Rs. 3/- per SMS) if you need any
additional advice or have any further questions or concerns. We appreciate
your time and attention to this important notication.
Yours sincerely,
For and on behalf of
Roche Diabetes Care India Private Limited
Nutan Kumari
Manager, Quality & Regulatory|
Omar Sherief Mohammad
Cluster Head – India, Middle East & Africa
---|---