BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 18139096 · Received November 15, 2023

    Report

    Report Number
    3011393376-2023-02571
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    October 17, 2023
    Report Date
    January 3, 2024
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    UDI-DI
    00365702719101
    PMA / PMN Number
    K160944
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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 THAT THE ACCU-CHEK GUIDE STRIPS WITH LOT 101829 HAD THE EXPIRATION DATE OF OF 28-NOV-2023 PRINTED ON THE LABEL OF THE VIAL. THE ALLEGED LABELING IS INCORRECT; THE CORRECT EXPIRATION DATE FOR LOT 101829 IS 28-NOV-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321732 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 101829 00365702719101

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male