BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1011471 · Received March 11, 2008

    Report

    Report Number
    1823260-2008-02294
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 18, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS HAVING LOW BLOOD GLUCOSE SYMPTOMS AND TESTED WITH RESULT OF 566 MG/DL WHILE USING THE ADVANTAGE SYSTEM. CUSTOMER TOOK THE MAX AMOUNT OF INSULIN ON SLIDING SCALE IN ADDITION TO WHAT HIS DR SAID TO TAKE OVER (12 UNITS OF HUMALOG) AND 10 MINS LATER FELT DISORIENTED AND DIZZY. CUSTOMER CALLED THE NURSE AND WAS INSTRUCTED TO CALL THE EMTS. CUSTOMER REPORTS EMTS ARRIVED WITHIN 5 MINS, TOOK HIS BLOOD GLUCOSE WITH A RESULT OF 46 MG/DL; WAS TREATED WITH A TUBE OF GLUCOSE, IV GLUCOSE, AND SALT SOLUTION. CUSTOMER REPORTS BEING TAKEN TO THE HOSPITAL WHERE THEY TESTED HIS BLOOD GLUCOSE BEFORE DINNER WITH A RESULT OF 94 MG/DL; CUSTOMER WAS ABLE TO TREAT HIMSELF BY EATING DINNER. NO CONTROLS WERE RUN. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT 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 549942

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention LANTUS 15-18 UNITS PM| HUMALOG SLIDING SCALE