BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2093775 · Received May 18, 2011

    Report

    Report Number
    1823260-2011-02626
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 30, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 145 MG/DL, 234 MG/DL, 166 MG/DL, 144 MG/DL, 76 MG/DL, AND 62 MG/DL. RESULTS WERE TAKEN WITH TWO VIALS OF STRIPS, SAME CODE NUMBER. CUSTOMER FELT HYPOGLYCEMIC SYMPTOMS OF LIGHT-HEADEDNESS AND DIZZINESS WITH THE READINGS. CUSTOMER DRANK 4 OUNCES OF (B)(6) AND FELT BETTER. 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 302864

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR ONE TOUCH ANIMAS INSULIN PEN| NOVOLOG