BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE

    MDR report key: 21334620 · Received February 7, 2025

    Report

    Report Number
    3011393376-2025-00251
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 31, 2025
    Report Date
    April 18, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    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 THAT THE EXPIRATION DATE PRINTED ON THE TEST STRIP VIAL WAS (27-SEP-2024). THE ACTUAL EXPIRATION DATE FOR LOT NUMBER 100438 IS (19-AUG-2019).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866906 ACCU-CHEK ® GUIDE BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. 100438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown