BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE

    MDR report key: 23378415 · Received October 24, 2025

    Report

    Report Number
    3011393376-2025-01038
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    October 16, 2025
    Report Date
    December 10, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    UDI-DI
    00365702719101
    PMA / PMN Number
    K160944
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: 222 MG/DL @ 01:00PM ON (B)(6) 2025, 98 MG/DL @ 01:02PM ON (B)(6) 2025. 123 MG/DL @ 03:00PM ON (B)(6) 2025, 379 MG/DL @ 03:02PM ON (B)(6) 2025. 341 MG/DL @ 03:00PM ON (B)(6) 2025, 141 MG/DL @ 03:02PM ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446124 ACCU-CHEK ® GUIDE BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. 105073 00365702719101

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male