BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1921199 · Received December 13, 2010

    Report

    Report Number
    1823260-2010-07376
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 30, 2010
    Report Date
    January 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN AVIVA METER, COMPARED TO A PROFESSIONAL METER, WITHIN 10 MINUTES: 300 MG/DL (AVIVA) AND 150 MG/DL (HOSPITAL'S METER). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 302995

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR NOVOLOG INSULIN| AGRANOX| DULOXETINE| SIMVASTATIN| OXYCODONE| METOPROLOL| PANTOPRAZOLE| GABAPENTIN| LANTUS INSULIN| METFORMIN| ASPIRIN