BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1770929 · Received November 13, 2007

    Report

    Report Number
    1823260-2007-09914
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    October 28, 2007
    Report Date
    November 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT SYSTEM WITHIN 10 MINUTES; 15 MG/DL, 187 MG/DL, AND 284 MG/DL. LOW BLOOD GLUCOSE SYMPTOMS REPORTED WITH THESE RESULTS; ABLE TO SELF TREAT. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR OMEPRAZOLE 20MG TWICE DAILY - 6 MONTHS| LEVOTHYROXINE 0.05MG 1/DAILY - 1-2 YEARS| DETROL LA 4MG ONCE DAILY - 1 YEAR| ALTACE 10MG ONCE DAILY - 1 YEAR| AMLODIPINE 10MG ONCE DAILY - 1 YEAR| BICITRA SOLUTION 30 UNITS - 2 YEARS 2/DAILY| ASPIRIN 81MG ONCE DAILY - 2-3 YEARS| MULTIVITAMIN EVERY OTHER DAY - MANY YEARS| METOPROLOL 50MG ONCE DAILY - 6 MONTHS