BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE

    MDR report key: 23252075 · Received October 9, 2025

    Report

    Report Number
    3011393376-2025-00998
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 16, 2025
    Report Date
    November 19, 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
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXPIRATION DATE LABELED ON THE TEST STRIP VIAL IS 03-SEP-2025. THE ACTUAL EXPIRATION DATE IS 09-MAR-2024 FOR LOT NUMBER 103347.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481977 ACCU-CHEK ® GUIDE BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. 103347

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female