BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK GUIDE TEST STRIPS

    MDR report key: 11766056 · Received May 3, 2021

    Report

    Report Number
    3011393376-2021-01383
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 3, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS UNSURE IF HE WAS USING STRIPS FROM LOT 101829, 101663, OR 101987. ALL TESTING WITH THE RETURNED STRIPS FROM LOTS 101829, 101663, AND 101987 PRODUCED ACCEPTABLE RESULTS.

    Additional Manufacturer Narrative · 1

    THIS CASE, WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 1), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 2).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 304 MG/DL (SYSTEM 1), 320 MG/DL (SYSTEM 1), AND 129 MG/DL (SYSTEM 2). IT IS UNKNOWN WHICH TEST STRIP LOT NUMBER WAS USED FOR SYSTEM 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662409 ACCU-CHEK GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 08256292001 ASKU 00365702719101

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR