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 Consequences Or Impact To Patient (2199)
Date of Event	04/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 154 mg/dl and 64 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: 9968338
• Report Number: 3011393376-2020-01423
• Device Sequence Number: 3676300
• Product Code: NBW
• UDI-Device Identifier: 00365702436107
• UDI-Public: 00365702436107
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 05/21/2020

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: 06/30/2021
• Device Model Number: 06908373001
• Device Catalogue Number: 06908373001
• Device Lot Number: 498552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 05/21/2020
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 77