BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1033990 · Received April 25, 2008

    Report

    Report Number
    1823260-2008-03578
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 6, 2008
    Report Date
    April 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K930979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT SHE COULDN'T TEST ON THE ADVANTAGE SYSTEM DUE TO POWER CONCERNS FOR 1-2 WEEKS. REPORTER STATED THAT DURING THIS TIME, SHE TOOK HER NORMAL DIABETIC MEDICATIONS IN THE MORNING AND THEN SOMETIME LATER SHE WAS UNABLE TO GET A READING AND PASSED OUT. SHE REPORTED THAT HER SON CALLED 911, THE EMTS TOOK HER TO THE HOSP, AND SHE WAS TREATED WITH PILLS AND AN INJECTION. REPORTER STATED SHE WAS HOSPITALIZED FOR FIVE DAYS AND NEW MEDICATIONS WERE ADDED TO HER REGIMEN. NO OTHER ACTIONS OR TREATMENT WERE REPORTED. A REQUEST WAS MADE FOR THE RETURN TO THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE - CGA CGA ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R GLYBURIDE - YEARS 5MG TWICE DAILY| MEDFORMIN - YEARS 500MG TWICE DAILY| LISINOPRIL HCTZ - 20-12.5MG TWICE DAILY| "NIFEDICRL XL" - FEW YEARS - 60MG TWICE DAILY| CARBEDIROL - 25MG TWICE DAILY