BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1913055 · Received December 2, 2010

    Report

    Report Number
    1823260-2010-07130
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 16, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 RESULTS OF 428 MG/DL AND 105 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    HILL-ROM HAS RECEIVED A REPORT ALLEGING THAT THE VEST MAY HAVE CONTRIBUTED TO A PT'S SEIZURE ACTIVITY; THE PT HAS A HISTORY OF SEIZURES, CNS DISORDER, AND TWO OTHER CHILDREN IN THE FAMILY PASSED AWAY HAVING SEIZURES WHILE THEY SLEPT. THE PT NO LONGER USED THE VEST. NO MALFUNCTION OF THE UNIT WAS ALLEGED NOR FOUND THROUGH AN ANALYSIS OF THE UNIT UPON ITS RETURN TO HILL-ROM. ALTHOUGH HILL-ROM HAS NOT RECEIVED A REPORT INDICATING THE INCREASE IN SEIZURE ACTIVITY REQUIRED MEDICAL INTERVENTION, A CONSERVATIVE REPORT IS BEING FILED WITH THE FDA.

    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 302349

    Patients

    Seq Age Sex Outcome Treatment
    1 053 YR LEVOTHYROXINE| METFORMIN| BYETTA| LISINOPRIL| "WELLCAL"| GLIPIZIDE| DIABETES VITAMIN PACK| ZYRTEC