BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA

    MDR report key: 1000142 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01660
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 25, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2. REFERENCE MEDWATCH REPORT WITH A1 PATIENT FOR THE SUSPECT DEVICE USED IN SYSTEM 1, (LOT NUMBER 300971, EXPIRATION DATE 05/31/2009).

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A BLOOD GLUCOSE RESULT OF 200 MG/DL ON THE AVIVA SYSTEM 1 AND THEN TAKING AN EXTRA 50 MG OF JANUVIA IN ADDITION TO THE 50 MG SHE NORMALLY TAKES. REPORTER STATED THAT 15 MINUTES LATER, SHE BEGAN FEELING HYPOGLYCEMIC SYMPTOMS. REPORTER INDICATED THAT HER FAMILY ATTEMPTED TO TREAT HER WITH SUGAR BUT SHE WAS UNABLE TO EAT IT SO THEY CALLED THE EMTS AND ATTEMPTED TO TEST HER ON AVIVA SYSTEM 2, BUT IT WOULD NOT TURN ON DUE TO POWER CONCERNS. REPORTER STATED THAT THE EMTS TOOK HER TO THE HOSPITAL WHERE A LOW RESULT WAS OBTAINED, SHE RECEIVED AN IV, WAS GIVEN A SANDWICH AND THEN RELEASED WITHIN 4 HOURS. 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 AVIVA BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R PLAVIX - 7 YEARS / 75 MG DAILY| DILTIAZEM - 7 YEARS / 240 MG DAILY| STARLIX - 7 YEARS / 60 MG DAILY| BYETTA - 1 YEAR / 1 SHOT DAILY| JANUVIA - 2 YEARS / 50 MG DAILY| METFORMIN - 7 YEARS / 2000 MG DAILY| HYDROCHLOROTHIAZIDE - 7 YEARS / 25 MG DAILY| ACCUPRIL - 7 YEARS / 80 MG DAILY