BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UA2 URIC ACID VER.2

    MDR report key: 9642848 · Received January 29, 2020

    Report

    Report Number
    1823260-2020-00234
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    January 8, 2020
    Report Date
    April 2, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KNK
    PMA / PMN Number
    K873363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE LAST CALIBRATION WAS OK. QUALITY CONTROLS WERE ACCEPTABLE. A GENERAL REAGENT ISSUE COULD BE RULED OUT AS CALIBRATION AND CONTROLS WERE ACCEPTABLE. UPON REVIEW OF THE ALARM TRACE, A LOW REAGENT ALARM WAS OBSERVED. MEDWATCH FIELD D11. HAS BEEN UPDATED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH UA2 URIC ACID VER.2 ON THREE DIFFERENT COBAS 8000 CLINICAL CHEMISTRY ANALYZERS. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS INITIALLY TESTED ON THE FIRST ANALYZER, RESULTING WITH A UA VALUE OF 80 UMOL/L. THE SAMPLE REPEATED THREE TIMES ON THIS ANALYZER, RESULTING WITH VALUES OF 75 UMOL/L, 0 UMOL/L ACCOMPANIED BY A DATA FLAG, AND 54 UMOL/L. THE SAMPLE WAS TESTED TWICE ON THE SECOND ANALYZER, RESULTING WITH UA VALUES OF -1 UMOL/L ACCOMPANIED BY A DATA FLAG AND 0 UMOL/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS TESTED ONCE ON THE THIRD ANALYZER, RESULTING WITH A UA VALUE OF 0 UMOL/L. ONE OF THE THREE ANALYZERS WAS A COBAS 8000 C (701) MODULE, WITH A SERIAL NUMBER OF 17J0-04. IT IS UNKNOWN WHICH OF THE THREE ANALYZERS THIS INFORMATION APPLIES TO. THE REPORTER NOTED THEY HAVE ALSO HAD ISSUES WITH PHOSPHORUS AND URINARY PROTEIN TESTS ON THIS ANALYZER. NO ADDITIONAL DETAILS WERE PROVIDED. THE MODEL AND SERIAL OF THE OTHER TWO ANALYZERS WERE REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106148 UA2 URIC ACID VER.2 URIC ACID TEST SYSTEM KNK ROCHE DIAGNOSTICS UA G2 435392

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR ENDOXAN (CYCLOPHOSPHAMID).| MABTHERA (RITUXIMAB).