BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1761318 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06356
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    July 5, 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
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. REFERENCE MEDWATCH REPORT (B)(4) FOR THE SUSPECT DEVICE USED IN THE COMPACT SYSTEM 2.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A BLOOD GLUCOSE RESULT OF 174 MG/DL ON COMPACT SYSTEM 1; HOWEVER, FELT HYPOGLYCEMIC SYMPTOMS. REPORTER STATED TAKING OUT THE TEST STRIP DRUM USED FOR TESTING AND THREW THE BOX AND DRUM CONTAINER AWAY AND PERFORMED A BACK TO BACK TEST USING A DIFFERENT TEST STRIP DRUM ON COMPACT SYSTEM 2 OF 59 MG/DL TAKEN THREE MINUTES FROM THE ORIGINAL RESULT. REPORTER INDICATED TAKING AN EXTRA DOSE OF 4 UNITS OF INSULIN AT THE TIME BECAUSE HE WAS GETTING READY TO SELF TREAT WITH CANDY AS WELL AS SELF TREATED WITH ORANGE JUICE AT THE TIME. NO OTHER ACTIONS WERE TAKEN OR TREATMENT 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR NPH INSULIN - 8YRS, 9UNITS, TWICE DAILY| REGULAR INSULIN - 8YRS, 8UNITS, TWICE DAILY| NPH INSULIN - 8YRS, 4UNITS, ONCE DAILY| LISINOPRIL - 2YRS, 20MG, ONCE DAILY| TOPROL - 2YRS, 25MG, ONCE DAILY| LIPITOR - 2YRS, 20MG, ONCE DAILY