BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK GUIDE TEST STRIPS

    MDR report key: 11405041 · Received March 3, 2021

    Report

    Report Number
    3011393376-2021-00715
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 18, 2021
    Report Date
    March 29, 2021
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    UDI-DI
    00365702719101
    PMA / PMN Number
    K160944
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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) 2021: 480 MG/DL, 250 MG/DL AND 168 MG/DL. ON (B)(6) 2021, THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 358 MG/DL, 238 MG/DL AND 163 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302860 ACCU-CHEK GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 08256292001 102171 00365702719101

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR