BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 2161178 · Received July 13, 2011

    Report

    Report Number
    1823260-2011-03722
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    July 2, 2011
    Report Date
    August 31, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 REPORTS BEING UNABLE TO TEST OBTAIN A RESULT ON THE AVIVA SYSTEM DUE TO AN ERROR ON THE DEVICE. CUSTOMER STATES HE TOOK NOVOLIN R AND LANTUS ANYWAY. THIRTY MINUTES LATER CUSTOMER WAS FOUND PASSED OUT; AN AMBULANCE WAS CALLED AND CUSTOMER TESTED 32 MG/DL ON PROFESSIONAL DEVICE. CUSTOMER WAS TREATED WITH AN INJECTION OF GLUCOSE AND TAKEN TO THE HOSPITAL. CUSTOMER WAS TREATED WITH ADDITIONAL GLUCOSE AND RELEASED 2 HOURS LATER. CUSTOMER STATES TEST STRIPS HAD BEEN LEFT IN HIS CAR. 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 303256

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR Required Intervention LANTUS| NOVOLIN R