BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URIC ACID VER.2

    MDR report key: 19557771 · Received June 18, 2024

    Report

    Report Number
    1823260-2024-01803
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 27, 2024
    Report Date
    July 11, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KNK
    UDI-DI
    04015630919154
    PMA / PMN Number
    K922762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE C501 ANALYZER IS (B)(6). THE CUSTOMER CHANGED THE REAGENT PACK AND A PATIENT SAMPLE PROCESSED WITH THE PACK HAD A CORRECT RESULT. NO FURTHER ISSUES WERE OBSERVED SINCE CHANGING THE PACK. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    CALIBRATION WAS ACCEPTABLE. CONTROLS RUN ON THE DAY OF THE EVENT WERE ACCEPTABLE. IT WAS DETERMINED THAT THE CUSTOMER DOES NOT RUN CONTROLS ON STANDBY REAGENT PACKS. STANDBY REAGENT PACKS MAY COME INTO USE DURING ROUTINE OPERATION. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDWATCH FIELD D4 HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH URIC ACID VER.2 ON A COBAS 6000 C501 MODULE. THE FIRST SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.6 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 7.69 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.5 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 5.41 MG/DL. THE THIRD SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.5 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 5.03 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338428 URIC ACID VER.2 URIC ACID TEST SYSTEM KNK ROCHE DIAGNOSTICS 75303401 04015630919154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown