BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 776994 · Received September 7, 2006

    Report

    Report Number
    1823260-2006-04945
    Event Type
    Malfunction
    Date Received
    September 7, 2006
    Date of Event
    August 15, 2006
    Report Date
    August 15, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED OBTAINING A BLOOD GLUCOSE RESULT OF 584 MG/DL, WHILE USING THE SUSPECT DEVICE. BASED ON THIS RESULT, PATIENT REPORTEDLY PHONED PHYSICIAN, WHO THEN PHONED EMERGENCY MEDICAL SERVICES ON PATIENT'S BEHALF. PATIENT STATED THAT, UPON THEIR ARRIVAL 5 MINUTES LATER, BLOOD GLUCOSE WAS RETESTED ON PARAMEDICS' DEVICE WITH A RESULT OF 101 MG/DL. PARAMEDIC REPORTEDLY ADVISED PATIENT THAT BLOOD PRESSURE WAS ELEVATED (230/180). PATIENT WAS SUBSEQUENTLY TRANSPORTED TO THE HOSPITAL FOR FURTHER EVALUATION. PATIENT INDICATED THAT SHE DOES NOT RECALL HAVING RECEIVED ANY TREATMENT AT THE HOSPITAL. WHILE ON THE LINE WITH TECHNICAL SUPPORT, A LEVEL-ONE CONTROL TEST WAS PERFORMED ON THE SUSPECT DEVICE AND THE RESULT FELL WITHIN THE ACCEPTABLE RANGE. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIAGNOSTICS NA 300256

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR ACCU-CHEK AVIVA BLOOD GLUCOSE MONITOR| AVIVA CONTROL SOLUTIONS| THERAPY DATES