BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1180459 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07189
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT COMFORT CURVE BLOOD GLUCOSE TEST STRIPS WERE LABELED WITH AN EXPIRATION DATE OF 04/30/09. THE MANUFACTURER'S BATCH RECORDS SHOW THE ACTUAL EXPIRATION DATE TO BE 04/30/08. REPORTER ALLEGED SHE OBTAINED A 123 MG/DL RESULT WHILE USING THE EXPIRED COMFORT CURVE STRIPS AND FEELING DIZZY. REPORTER STATED SHE PASSED OUT, ANOTHER RESULT OF 50 MG/DL WAS OBTAINED ON THE SAME STRIPS, SHE WENT HOME AND THEN PASSED OUT AGAIN. REPORTER STATED ANOTHER RESULT OF 193 MG/DL WAS OBTAINED ON THE SAME STRIPS, 911 WAS CALLED AND THE PARAMEDICS OBTAINED A RESULT OF 82 MG/DL BEFORE TREATING HER WITH A GLUCOSE SHOT. REPORTER STATED SHE WAS TAKEN TO THE HOSPITAL, MORE TESTING WAS DONE, AND SHE WAS GIVEN FOOD BEFORE BEING RELEASED 10 HOURS LATER. 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 549605

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention BENICAR - 16 YEARS| GLUCOPHAGE - 18 YEARS| SIMVASTATIN - 6 MONTHS| TRAZODONE - 2 YEARS| LEXAPRO - 14.5 YEARS