BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE

    MDR report key: 21867402 · Received April 18, 2025

    Report

    Report Number
    3011393376-2025-00558
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    April 11, 2025
    Report Date
    May 1, 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
    PA, 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: 375 MG/DL AND A RESULT BETWEEN 170-180 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24077 ACCU-CHEK ® GUIDE BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. 105321 00365702719101

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male