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 Codes	Hypoglycemia (1912); Shaking/Tremors (2515)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case, with patient identifier (b)(4) (system 2), is related to case with patient identifier (b)(4) (system 1).
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 257 mg/dl and 281 mg/dl (system 1) and 115 mg/dl and 131 mg/dl (system 2).

• 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
• MDR Report Key: 12076007
• Report Number: 3011393376-2021-01942
• Device Sequence Number: 3592520
• Product Code: NBW
• UDI-Device Identifier: 00365702438101
• UDI-Public: 00365702438101
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160944
• 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): 08/30/2021

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: 11/30/2021
• Device Model Number: 06908349001
• Device Catalogue Number: 06908349001
• Device Lot Number: 498777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 109