BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1780359 · Received September 14, 2007

    Report

    Report Number
    1823260-2007-08093
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    August 25, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A HIGH BLOOD GLUCOSE VALUE OF 535 MG/DL ON HIS ADVANTAGE SYSTEM AND WENT TO THE EMERGENCY ROOM (ER) AS A RESULT. REPORTER STATED HE WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS OF SHAKING AT THE TIME AND WHEN ARRIVING AT THE ER, THEIR MEASUREMENT WAS EITHER 44 OR 53 MG/DL PERFORMED 15 MINUTES LATER. REPORTER INDICATED BEING TREATED WITH ORANGE JUICE AND A BAR, TYPE NOT PROVIDED. NO OTHER ACTIONS WERE REPORTED 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549731

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR VYTORYN - 2YRS - 40MG DOSING UNK| AMARYL - 2YRS - 2MG DOSING UNK| VITAMIN - 2YRS - DOSE UNK| AVAPRO - 2YRS - 300MG DOSING UNK| METFORMIN - 2YRS - 100MG DOSING UNK| BAYER - 2YRS - "LOW DOSE" UNK| TRICOR - 2YRS - 145MG DOSING UNK| ROSIGLITAZONE - 2 YRS - 4MG DOSING UNK