BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® AVIVA

    MDR report key: 1841366 · Received September 22, 2010

    Report

    Report Number
    1823260-2010-05621
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER REPORTS BEING UNABLE TO OBTAIN A RESULT ON THE AVIVA SYSTEM DUE TO AN ERROR ON THE DEVICE. CALLER BELIEVES CUSTOMER MAY HAVE HAD LOW BLOOD GLUCOSE SYMPTOMS AT THE TIME AN ATTEMPT WAS MADE TO USE THE DEVICE. AT 2 HOURS LATER, CUSTOMER WENT TO A ROUTINE PHYSICIAN'S APPOINTMENT AND TESTED 68 MG/DL ON PROFESSIONAL DEVICE. CUSTOMER WAS ADMITTED TO THE HOSPITAL DUE TO LOW BLOOD PRESSURE, AND WAS TREATED WITH TWO TUBES OF ORAL GLUCOSE AFTER TESTING 68 MG/DL. CUSTOMER WAS RELEASED FROM THE HOSPITAL TWO DAYS LATER. REQUESTED RETURN OF SUSPECT DEVICE, AND REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R WHEELCHAIR| LANTUS AT NIGHT| NOVOLOG