BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 4203108 · Received October 27, 2014

    Report

    Report Number
    1823260-2014-08277
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 29, 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). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 493518, EXPIRATION DATE 08/31/2015). REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED THE FOLLOWING AVIVA COMBO SYSTEM 1/AVIVA COMBO SYSTEM 2 RESULTS WITHIN 10 MINUTES: 421 MG/DL AND 160 MG/DL, 519 MG/DL AND 180 MG/DL. 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
    682863 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 493518

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female