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

Model Number	06908373001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 542 mg/dl and 224 mg/dl.

• 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: 10140261
• Report Number: 3011393376-2020-02049
• Device Sequence Number: 1848008
• Product Code: NBW
• UDI-Device Identifier: 00365702436107
• UDI-Public: 00365702436107
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/09/2020

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: 08/31/2020
• Device Model Number: 06908373001
• Device Catalogue Number: 06908373001
• Device Lot Number: 498127
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 06/21/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/09/2020
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 82