BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1023398 · Received April 2, 2008

    Report

    Report Number
    1823260-2008-02923
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 9, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY REC'D THE FOLLOWING RESULTS ON THE COMPACT SYSTEM WITHIN 10 MINUTES: 89 MG/DL, 63 MG/DL, 46 MG/DL,K AND 58 MG/DL. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS, AND CUSTOMER WAS TREATED WITH SODA (UNABLE TO SELF TREAT); SYMPTOMS IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER, THE CUSTOMER DID NOT RETURN THE TEST STRIPS; REPLACEMENT 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 20659941

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention HUMULIN R - SCALE/PN MEAL - 9-12 YEARS| HUMULIN 2 20UNITS DINNER - 9-12 YEARS| IRON PILLS - 300MG AS NEEDED - 2 YEARS| VITAMIN C WITH D - 650MG/DAY - 8-MONTHS| LISINOPRIL HC - 20MG| RANITIDINE - 300MG| HUMLIN N - 20UNITS BREAKFAST| HUMULIN R - 20UNITS AM MEAL| VITAMIN E - 1/DAY