BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 3961507 · Received July 28, 2014

    Report

    Report Number
    1823260-2014-05576
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 28, 2025
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE AVIVA NANO SYSTEM (LOT NUMBER 491987, EXPIRATION DATE 06/30/2015). (B)(6).

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A RESULT OF 318 MG/DL ON THE AVIVA NANO SYSTEM, AND A RESULT OF 117 MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. ON A DIFFERENT OCCASION CUSTOMER RECEIVED A RESULT OF 220 MG/DL ON THE AVIVA NANO SYSTEM, AND A RESULT OF 93 MG/DL ON THE AVIVA SYSTEM WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438034 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491987

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male