BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 16546445 · Received March 15, 2023

    Report

    Report Number
    3011393376-2023-00662
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 26, 2023
    Report Date
    March 22, 2023
    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
    IL, 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: (B)(6) 2023: 430 MG/DL AT 5:00PM, 136 MG/DL AT 5:10PM. (B)(6) 2023: 420 MG/DL AT 5:00PM, 115 MG/DL AT 5:10PM. (B)(6) 2023: 415 MG/DL AT 5:10PM, 134 MG/DL AT 5:20PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768835 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 08256292001 103732 00365702719101

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male