BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URIC ACID VER.2

    MDR report key: 20924999 · Received December 13, 2024

    Report

    Report Number
    1823260-2024-03662
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 28, 2024
    Report Date
    February 11, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KNK
    UDI-DI
    04015630925124
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    B7 OTHER RELEVANT HISTORY WAS UPDATED. GENERAL REAGENT ISSUES COULD BE RULED OUT AS CALIBRATION AND QC WAS INCONSPICUOUS, OTHER PATIENT SAMPLES WERE INCONSPICUOUS, AND DIFFERENT SAMPLES FROM THE SAME PATIENT GAVE MATCHING RESULTS. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE URIC ACID (UA2) RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 CORE UNIT INSTRUMENT. TWO SAMPLES FROM THE SAME PATIENT WERE TESTED WHERE ONE RESULT WAS 120 UMOL/L AND THE OTHER RESULT WAS <12 UMOL/L. THE INITIAL RESULT OF 120 UMOL/L WAS QUESTIONED AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. THE SAMPLE WAS REPEATED TWICE AND THE RESULT WAS <12 UMOL/L BOTH TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409751 URIC ACID VER.2 URIC ACID TEST SYSTEM KNK ROCHE DIAGNOSTICS 5171857190 802892 04015630925124

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male