BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE

    MDR report key: 25000949 · Received April 27, 2026

    Report

    Report Number
    3011393376-2026-00248
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    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 ON (B)(6) 2026: 97 MG/DL (USER'S METER) AND 54 MG/DL (DIFFERENT ROCHE METER). IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2026: 94 MG/DL (USER'S METER) AND 55 MG/DL (DIFFERENT ROCHE METER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310690 ACCU-CHEK ® GUIDE BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female