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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK AVIVA PLUS TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS
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ROCHE DIABETES CARE, INC. ACCU-CHEK AVIVA PLUS TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS Back to Search Results
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 04/26/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This case, with patient identifier (b)(6) (system 2), is related to case with patient identifier (b)(6) (system 1).
 
Event or Problem Description
It was reported the patient received the following results within 15 minutes using two blood glucose monitors: 578 mg/dl and a result in the 140's (mg/dl) with the guide meter (system 1) and 137 mg/dl with the aviva meter (system 2).
 
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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 Key11792458
Report Number3011393376-2021-01450
Device Sequence Number11843180
Product Code NBW
UDI-Device Identifier00365702438101
UDI-Public00365702438101
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K160944
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/25/2021
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 Date08/31/2021
Device Model Number06908349001
Device Catalogue Number06908349001
Device Lot Number498673
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/26/2021
Supplement Date Received by Manufacturer06/22/2021
Initial Report FDA Received Date05/07/2021
Supplement Report FDA Received Date06/25/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age72 YR
Patient Weight88
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