BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 3800727 · Received May 8, 2014

    Report

    Report Number
    1823260-2014-03318
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 22, 2014
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). IT IS NOT KNOWN WHICH SYSTEM PRODUCED WHICH RESULT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A RESULT OF 20 MMOL/L ON ONE AVIVA SYSTEM AND A RESULT OF 4.6 MMOL/L ON A DIFFERENT 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
    278809 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491719

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female UNK DIALYSIS| UNK DIALYSIS