BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 15825937 · Received November 18, 2022

    Report

    Report Number
    3011393376-2022-03415
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    November 6, 2022
    Report Date
    December 13, 2022
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 430 MG/DL (SYSTEM 1/STRIP LOT 103405) AND 193 MG/DL (SYSTEM 2/UNKNOWN STRIP LOT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238780 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 08256292001 103405 00365702719101

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male