BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK GUIDE TEST STRIPS

    MDR report key: 9805067 · Received March 9, 2020

    Report

    Report Number
    3011393376-2020-00862
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 10, 2020
    Report Date
    July 17, 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
    TX, 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) 2020: 115 MG/DL, 64 MG/DL, AND 294 MG/DL. (B)(6) 2020: 153 MG/DL, 87 MG/DL, AND 233 MG/DL. (B)(6) 2020: 130 MG/DL, 73 MG/DL, AND 144 MG/DL. IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 115 MG/DL, 64 MG/DL AND 294 MG/DL, 153 MG/DL, 87 MG/DL AND 233 MG/DL, AND 130 MG/DL, 73 MG/DL AND 144MG/DL. EACH SET OF TESTS WERE PERFORMED ON DIFFERENT DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268220 ACCU-CHEK GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 101541

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR