BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 3253226 · Received July 29, 2013

    Report

    Report Number
    1823260-2013-04547
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 29, 2013
    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
    UK
    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 AND EXPIRATION DATE UNKNOWN). (B)(6).

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULT OF 19.2 MMOL/L ON THE MOBILE SYSTEM AND A RESULT IF 8.6 MMOL/L ON THE AVIVA NANO SYSTEM WITHIN 10 MINUTES. ON A DIFFERENT DATE CUSTOMER RECEIVED RESULT OF 6.4 MMOL/L ON THE MOBILE SYSTEM AND A RESULT IF 3.1 MMOL/L ON THE AVIVA NANO SYSTEM WITHIN 10 MINUTES. THE CUSTOMER REPORTED FEELING UNWELL WITH THESE RESULTS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER THE CUSTOMER NO LONGER HAS THE TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352862 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male UNKNOWN INSULIN| UNKNOWN INSULIN