BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1954697 · Received January 10, 2011

    Report

    Report Number
    1823260-2011-00145
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 26, 2010
    Report Date
    March 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LOW BLOOD GLUCOSE SYMPTOMS WITH RESULT OF 109 MG/DL OBTAINED ON THE AVIVA SYSTEM. AMBULANCE WAS CALLED, AND CUSTOMER TESTED 32 MG/DL ON PROFESSIONAL DEVICE WITHIN 10 MINUTES OF RESULT OF 109 MG/DL. CUSTOMER WAS TREATED WITH AN IV CONTAINING GLUCOSE AND TAKEN TO THE HOSPITAL. CUSTOMER WAS GIVEN JUICE AND GRAHAM CRACKERS AND KEPT IN THE HOSPITAL OVERNIGHT. LOW BLOOD GLUCOSE SYMPTOMS IMPROVED 3-4 HOURS AFTER ARRIVING AT THE HOSPITAL. 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 302553

    Patients

    Seq Age Sex Outcome Treatment
    1 030 YR NOVOLOG| CYMBALTA| OXYCODONE| LANTUS| LAMOTRIGINE| "GAPATIN"| HYDROXYZINE| DIPHENHYDRAMINE| RISPERIDONE