BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1761323 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06362
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    July 6, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A BLOOD GLUCOSE RESULT OF 600 MG/DL ON HER COMPACT PLUS SYSTEM HOWEVER WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS AT THE TIME SO SHE DID NOT TAKE ANY ADDITIONAL DIABETIC MEDICATIONS AS A RESULT. REPORTER STATED OBTAINING A RESULT OF 112 MG/DL ON THE SAME SYSTEM THAT WAS PERFORMED 8 MINUTES AFTER THE ORIGINAL RESULT. REPORTER INDICATING SELF TREATING WITH CANDY AND NO OTHER ACTIONS WERE 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 20665041

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR WATER PILL - 2YRS - ONCE DAILY| METFORMIN - 1 MO - 1000MG TWICE DAILY| PLAVIX - 10YRS - ONCE DAILY| ALTACE - SINCE 1990 - 20MG TWICE DAILY| LANTUS - 3 YRS - 35UNITS ONCE DAILY| ASPIRIN - SINCE 5/27/07 - ONCE DAILY| THYROID MEDICATION - 10YRS - ONCE DAILY