BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2875240 · Received December 17, 2012

    Report

    Report Number
    1823260-2012-06344
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 19, 2012
    Report Date
    January 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 COMBO SYSTEM (LOT NUMBER 490582, EXPIRATION DATE 03/31/2013). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE MOBILE SYSTEM. WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULT OF 107 MG/DL ON THE AVIVA COMBO SYSTEM, AND A RESULT OF 64 MG/DL ON THE MOBILE SYSTEM WITHIN 10 MINUTES WITH THE SAME BLOOD DROP. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER TEST STRIPS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 490582

    Patients

    Seq Age Sex Outcome Treatment
    1