BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1011684 · Received March 10, 2008

    Report

    Report Number
    1823260-2008-02277
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A BLOOD GLUCOSE RESULT OF 488 MG/DL COMPARED TO THE DOCTOR'S MEASUREMENT OF 200 MG/DL ON THE COMPACT PLUS SYSTEM WHEN TESTING WAS PERFORMED BACK TO BACK WITHIN THE SAME TIME. REPORTER STATED THE CUSTOMER HAD BEEN OBTAINING HIGHER SYSTEM READINGS AND WENT TO THE DOCTOR TO TEST GLUCOSE. REPORTER INDICATED THE CUSTOMER WAS TREATED WITH INSULIN, AMOUNT NOT KNOWN. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT WAS RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS 20667441

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR ACTOS 1.5 YRS 45 MG ONCE DAILY| NORVASC 1.5YRS 10 MG FREQUENCY UNK| GLIPIZIDE, 20 MG ONCE DAILY| COZAAR, 1.5 YRS 100 MG FREQUENCY UNK| ATENOLOL, 1.5 YRS 25 MG ONCE DAILY| ACTOS, 1.5 YRS 15 MG ONCE DAILY| GLIPIZIDE "SINCE SATURDAY" 40 MG ONCE DAILY