BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040140 · Received May 8, 2008

    Report

    Report Number
    1823260-2008-03864
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 2, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    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 RESULT OF 480 MG/DL ON THE ADVANTAGE SYSTEM AND THEN TAKING AN UNKNOWN AMOUNT OF NOVOLOG AND ALSO LANTUS INSULIN. REPORTER STATED THAT HIS ROOMMATE FOUND HIM PASSED OUT ON THE FLOOR ABOUT 6 HOURS LATER, OBTAINED A RESULT OF 87 MG/DL ON HIS SAME ADVANTAGE SYSTEM, AND HELPED HIM INTO BED. HE REPORTED THAT HE CALLED THE PARAMEDICS THE NEXT DAY BECAUSE HIS FOOT WAS HURTING. REPORTED THAT HE WAS DIAGNOSED WITH AND TREATED FOR A BROKEN FOOT AND ALSO TREATED WITH HIS NORMAL MEDICATIONS. NO OTHER ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT RECEIVED. REPORTER STATED HE WAS USING STRIPS STORED OUTSIDE OF THE VIAL AND INSIDE HIS CARRYING CASE WHICH LABELING ADVISES AGAINST. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R LANTUS - 11 UNITS DAILY| NOVOLOG - SLIDING SCALE