BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761329 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06349
    Event Type
    Other
    Date Received
    July 20, 2007
    Date of Event
    June 21, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDICAL OPINION WAS PROVIDED BY ENDOCRINOLOGIST DR. CHARLES CLARK WHICH STATES THE FOLLOWING: ADA SELF MONITORING BLOOD GLUCOSE GOALS FOR GESTATIONAL DIABETES ARE FASTING 60-90MG/DL, PRE-MEAL OF 60-105MG/DL, AND 2 HOUR POSTPRANDIAL OF <120 MG/DL. IF THE CUSTOMER TOOK MORE INSULIN THAN NECESSARY THAT SHOULD HAVE MADE HER BABY BETTER OFF AND IS UNRELATED TO THE CESAREAN SECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS ON THE ADVANTAGE SYSTEM CONSISTENT WITH THE HOSPITAL'S RESULTS ON TWO OCCASIONS WHEN A COMPARISON WAS PERFORMED WITHIN 10 MINUTES. CUSTOMER ALLEGES THAT SHE TOOK INSULIN BASED ON RESULTS IN THE 200'S MG/DL FROM THE ADVANTAGE SYSTEM AND WOULD SUBSEQUENTLY FEEL LOW BLOOD GLUCOSE SYMPTOMS A "FEW" HOURS LATER. CUSTOMER REPORTS EATING WHEN THIS WOULD OCCUR. CUSTOMER ALLEGES THAT SINCE SHE HAS BEEN TAKING INSULIN BASED ON THE DEVICE RESULTS WHICH SHE CLAIMS ARE TOO HIGH, SHE HAS TO HAVE CESAREAN SECTION A MONTH EARLY. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, CUSTOMER DECLINED RETURNING SUSPECT DEVICE.

    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 549711

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR HUMULIN N - ABOUT 7 WEEKS, 45 UNITS, AM| HUMULIN N - ABOUT 7 WEEKS, 35 UNITS, PM| PRENATAL VITAMINS - ABOUT 35 WEEKS| LEVOXYL - UNKNOWN DOSAGE| NOVOLOG - ABOUT 7 WEEKS, 6-12 UNITS, SLIDING SCALE