BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 3190871 · Received June 26, 2013

    Report

    Report Number
    1823260-2013-03872
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 3, 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
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE AVIVA NANO SYSTEM WITHIN 1 MINUTE: 20.6 MMOL/L AND 8.0 MMOL/L. THE CUSTOMER TOOK 3 UNITS OF HUMALOG INSULIN BASED ON THE RESULT OF 8.0 MMOL/L. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290295 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491528

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female HUMALOG| HUMALOG