BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 18534054 · Received January 18, 2024

    Report

    Report Number
    3011393376-2024-00169
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    January 7, 2024
    Report Date
    January 25, 2024
    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
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING SETS OF RESULTS ON (B)(6) 2024: 177 MG/DL,112 MG/DL,151 MG/DL AND 85 MG/DL WITHIN 15 MINUTES 79 MG/DL,103 MG/DL AND 147 MG/DL WITHIN 15 MINUTES. IT WAS ALSO REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2024: 214 MG/DL AND 104 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852809 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 104317 00365702719101

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male