MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® AVIVA PLUS; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number	06908268001
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was alleged by the patient that the expiration date printed on the test strip vial was "2025 (b)(4)" which is invalid.The actual expiration date should be labeled as (2024 (b)(4)) on the test strip vial for lot number (690378).The test strips are expired.
Additional Manufacturer Narrative
Correction - the test strip lot number was updated in section d4 based on the returned product.

• Brand Name: ACCU-CHEK ® AVIVA PLUS
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; na; indianapolis IN 46250 1025
• Manufacturer Contact: brian frazier ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 21292014
• Report Number: 3011393376-2025-00225
• Device Sequence Number: 9208012
• Product Code: LFR
• UDI-Device Identifier: 00365702408104
• UDI-Public: 00365702408104
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 06908268001
• Device Lot Number: 690377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 99 KG