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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 06/18/2021
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: 264 mg/dl, 271 mg/dl, lo mg/dl, 287 mg/dl and 80 mg/dl.
 
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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 Key12085573
Report Number3011393376-2021-01978
Device Sequence Number14283655
Product Code NBW
UDI-Device Identifier00365702438101
UDI-Public00365702438101
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K101299
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) 07/27/2021
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 Date10/31/2021
Device Model Number06908349001
Device Catalogue Number06908349001
Device Lot Number498751
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2021
Initial Date Received by Manufacturer 06/18/2021
Supplement Date Received by Manufacturer07/23/2021
Initial Report FDA Received Date06/29/2021
Supplement Report FDA Received Date07/27/2021
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
UNKNOWN INSULIN.; UNKNOWN INSULIN.
Patient Age62 YR
Patient Weight95
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