BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK GUIDE TEST STRIPS

    MDR report key: 10477949 · Received September 1, 2020

    Report

    Report Number
    3011393376-2020-03144
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 11, 2020
    Report Date
    October 28, 2020
    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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE, WITH PATIENT IDENTIFIER (B)(6), IS RELATED TO CASE WITH PATIENT IDENTIFIER .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: ON (B)(6) 2020: 120 MG/DL(AVIVA), 294 (GUIDE), 204 MG/DL (GUIDE). ON (B)(6) 2020: 243 MG/DL (GUIDE), 111 MG/DL (AVIVA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942214 ACCU-CHEK GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 08256292001 101609 00365702719101

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR