BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1860806 · Received October 7, 2010

    Report

    Report Number
    1823260-2010-05994
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    October 4, 2010
    Report Date
    January 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE AVIVA SYSTEM (LOT NUMBER 302359, EXPIRATION DATE 06/30/2011). REFERENCE MEDWATCH REPORT WITH (B)(6)FOR THE SUSPECT DEVICE USED IN THE COMPACT PLUS SYSTEM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE NECK FLANGE EYELETS TORE. THUS LEAVING THE TRACHEOSTOMY TUBE UNSECURED. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 7.4 MMOL/L ON THE AVIVA SYSTEM AND 0.6 MMOL/L ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES. 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 302359

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR "TORONTO" INSULIN| METFORMIN 3 TIMES DAILY| NPH INSULIN