BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA PLUS TEST STRIPS

    MDR report key: 12075927 · Received June 28, 2021

    Report

    Report Number
    3011393376-2021-01940
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 8, 2021
    Report Date
    July 21, 2021
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    UDI-DI
    00365702408104
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES (B)(6) 2021: 460 MG/DL AND 117 MG/DL. IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES (B)(6) 2021: 118 MG/DL AND 257 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972016 ACCU-CHEK AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 06908268001 499021 00365702408104

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR