BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK GUIDE TEST STRIPS

    MDR report key: 10254164 · Received July 9, 2020

    Report

    Report Number
    3011393376-2020-02403
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 12, 2020
    Report Date
    September 28, 2020
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    UDI-DI
    00365702712102
    PMA / PMN Number
    K160944
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 74 MG/DL (LOT 101285) AND 173 MG/DL (LOT 101434).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714795 ACCU-CHEK GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 07453744001 101285 00365702712102

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR