BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE

    MDR report key: 20638282 · Received November 8, 2024

    Report

    Report Number
    3011393376-2024-02287
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    November 7, 2024
    Report Date
    January 17, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 6.3 MMOL/L AT 22:11. 12.2 MMOL/L AT 22:25. 10.5 MMOL/L AT 22:26.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952714 ACCU-CHEK ® GUIDE BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. 104947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female