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

Model Number	06908349001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Caller reportedly received the following results on an aviva meter, compared to a professional meter, within 15 minutes: 182 mg/dl (aviva) and 89 mg/dl (doctor's meter).The test strips are currently expired, however the customer reported that the test strips were not expired at the time of the comparison.
Additional Manufacturer Narrative
The test strips are currently expired, however the customer reported that the test strips were not expired at the time of the comparison.
Additional Manufacturer Narrative
Device received in a condition, which made analysis impossible.Unable to test returned test strips, because they expired.

• Brand Name: ACCU-CHEK ® AVIVA PLUS TEST STRIPS
• 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: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 14241115
• Report Number: 3011393376-2022-01274
• Device Sequence Number: 14552508
• Product Code: NBW
• UDI-Device Identifier: 00365702438101
• UDI-Public: 00365702438101
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K101299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: 07/31/2020
• Device Model Number: 06908349001
• Device Catalogue Number: 06908349001
• Device Lot Number: 498084
• 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: 04/15/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: METFORMIN
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 92 KG