BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UA2

    MDR report key: 17309412 · Received July 12, 2023

    Report

    Report Number
    1823260-2023-02234
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    June 15, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KNK
    UDI-DI
    04015630919154
    PMA / PMN Number
    K922762
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION DATA SHOW THAT THERE WAS A CALIBRATION FACTOR CHANGE OF 10 ON (B)(6) 2023, INDICATING A USER ERROR DURING CALIBRATION. THE FIELD SERVICE ENGINEER CLEANED THE INTERNAL CONTAINER OF THE INSTRUMENT AND PIPETTES. CALIBRATION, QUALITY CONTROLS, AND PATIENT SAMPLE COMPARISON WERE PERFORMED; ALL RESULTS WERE ACCEPTABLE. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARM WAS OBSERVED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE IS CONSISTENT WITH A USER ERROR DURING CALIBRATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT URINE SAMPLES TESTED WITH UA2 (URIC ACID VER.2) ON A COBAS 4000 C311. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN AS THE PATIENTS HAD "NORMAL" SERUM VALUES. PATIENT SAMPLE 1: THE SAMPLE INITIALLY RESULTED IN A UA2 VALUE OF 3.29 MG/DL. THE SAMPLE WAS REPEATED ON A COBAS C 501 MODULE, RESULTING IN A VALUE OF 31.72 MG/DL. PATIENT SAMPLE 2: THE SAMPLE INITIALLY RESULTED IN A UA2 VALUE OF 3.0 MG/DL. THE SAMPLE WAS REPEATED ON A COBAS C 501 MODULE, RESULTING IN A VALUE OF 32 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770914 UA2 URIC ACID TEST SYSTEM KNK ROCHE DIAGNOSTICS NA 66109001 04015630919154

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male