BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK METER

    MDR report key: 19658836 · Received July 1, 2024

    Report

    Report Number
    MW5156920
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 30, 2024
    Report Date
    July 1, 2024
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLING, STATING HE RECEIVED A PRESCRIPTION FOR A NEW ACCU-CHEK GLUCOSE METER ON (B)(6) 2024. REPORTER STATES THAT ON APPROXIMATELY (B)(6) 2024, THE ACCU-CHEK METER FAILED. REPORTER STATES HE HAD TO INSERT FIVE BLOOD GLUCOSE TEST STRIPS AND THE ACCU-CHEK STILL WOULD NOT PROVIDE A BLOOD GLUCOSE READING. REPORTER STATES HE IS NOW OUT OF TEST STRIPS AND MUST BUY SOME NEW ONES AS WELL AS A FUNCTIONING ACCU-CHEK METER SO THAT HE CAN CONTINUE TO MONITOR HIS BLOOD GLUCOSE LEVELS. REPORTER ADDITIONALLY STATES THAT TODAY HE RECEIVED A "MEDICAL DEVICE CORRECTION LETTER" IN THE MAIL STATING HIS ROCHE DIABETES ACCU-CHEK METER HE RECENTLY PURCHASED MAY BE PROBLEMATIC. REPORTER STATES HE RECEIVED HIS ACCU-CHEK METER FROM "WALMART PHARMACY; (B)(6)". REPORTER STATES HE IS GOING TO CONTACT HIS PHARMACY ABOUT OBTAINING AN ACCU-CHEK REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800887 ACCU-CHEK METER SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW ROCHE DIABETES CARE, INC. 923

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male BLOOD GLUCOSE TEST STRIPS