BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 19886195 · Received August 1, 2024

    Report

    Report Number
    3011393376-2024-01613
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Report Date
    August 30, 2024
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    PMA / PMN Number
    K160944
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 ON 16-JUL-2024: 346 MG/DL, 149 MG/DL AND 157 MG/DL. IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON 23-JUL-2024: 380 MG/DL, 110 MG/DL, 98 MG/DL AND 426 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740280 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 104786

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female METFORMIN 500 MG/2X/DAY