BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK GUIDE TEST STRIPS

    MDR report key: 10406736 · Received August 14, 2020

    Report

    Report Number
    3011393376-2020-02935
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    August 2, 2020
    Report Date
    November 10, 2020
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    PMA / PMN Number
    K160944
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2020: 38 MG/DL AND 130 MG/DL AND ON 3 AUGUST 2020: 52 MG/DL AND 132 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875886 ACCU-CHEK GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1