BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 14039259 · Received April 7, 2022

    Report

    Report Number
    3011393376-2022-01076
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    March 26, 2022
    Report Date
    June 9, 2022
    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
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2022: 275 MG/DL, 150 MG/DL, AND 97 MG/DL. ON A DIFFERENT DAY, THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 375 MG/DL AND 140 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824712 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 06908268001 690070 00365702408104

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male