BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK ACTIVE

    MDR report key: 707745 · Received May 2, 2006

    Report

    Report Number
    1823260-2006-01900
    Event Type
    Death
    Date Received
    May 2, 2006
    Date of Event
    February 8, 2006
    Report Date
    April 3, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED SHE USED THE DEVICE TO CHECK HER BLOOD GLUCOSE DURING HER PREGNANCY DUE TO GESTATIONAL DIABETES. SHE SAID THE BATTERIES IN THE DEVICE BECAME DRAINED AND SHE REPLACED THEM. IN REPLACING THE BATTERIES, SHE SAID THE DEVICE MEMORY WAS ERASED. SHE USED THE DEVICE WITH THE NEW BATTERIES AND THE MEMORY WORKED. SHE REMOVED THE NEW BATTERIES TO SEE IF SHE COULD DUPLICATE THE MEMORY BEING ERASED AND SHE WAS UNSUCCESSFUL. SHE WAS PLACED ON 5MG OF GLYBURIDE 1X/DAY. SHE SAID HER GLYBURIDE DOSE WAS CHANGED TO 10MG PER DAY (7.5MG AM AND 2.5MG PM). SHE STATED THE DEVICE RESULTS WERE NORMAL - BETWEEN 80-130MG/DL. HER HBA1C HAD BEEN GETTING HIGHER AT EACH DOCTOR VISIT, UNTIL HER LAST VISIT, WHICH HAD AN HBA1C RESULT OF 9.0. WHEN SHE COMPARED HER DEVICE WITH THE DOCTOR'S METER, THEY WERE ONE POINT FROM EACH OTHER - HER GLUCOSE WAS 126 MG/DL. TWO DAYS LATER, AT A ROUTINE VISIT, THERE WAS NO HEARTBEAT FROM THE FETUS. THE NEXT DAY, SHE WAS GIVEN AN EMERGENCY CESAREAN SECTION. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE BLOOD GLUCOSE NBW ROCHE DIAGNOSTICS NA 22921132

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death| R