BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 19079943 · Received April 10, 2024

    Report

    Report Number
    3011393376-2024-00808
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 6, 2024
    Report Date
    April 18, 2024
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    UDI-DI
    00365702710108
    PMA / PMN Number
    K160944
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 250-350 MG/DL AND 120-139 MG/DL. SUCH READINGS OCCURRED ON TWO OR THREE OCCASIONS OVER THE PREVIOUS 2-3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427933 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 104566 00365702710108

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male