BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UA2

    MDR report key: 16708534 · Received April 10, 2023

    Report

    Report Number
    1823260-2023-01180
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    February 21, 2023
    Report Date
    August 22, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KNK
    UDI-DI
    07613336121580
    PMA / PMN Number
    K873363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED ADDITIONAL INFORMATION IN RELATION TO THE 9 COMPLAINED PATIENT SAMPLES. REFER TO THE ATTACHMENT FOR THE PATIENT DATA, INCLUDING RELEVANT TEST DATA FOR SOME OF THE SAMPLES.

    Additional Manufacturer Narrative · 0

    CALIBRATION AND CONTROLS RECOVERED WITHIN SPECIFICATIONS. A GENERAL PRODUCT ISSUE CAN BE EXCLUDED. UPON REVIEW OF THE ALARM TRACE, ABNORMAL ASPIRATION ALARMS TOOK PLACE ON (B)(6)2023 AND (B)(6)2023. A HARDWARE CHECK WAS PERFORMED AND WAS WITHIN SPECIFICATIONS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE. THE ISSUE IS CONSISTENT WITH INCORRECT PRE-ANALYTIC SAMPLE HANDLING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR NINE PATIENT SAMPLES TESTED WITH UA2 URIC ACID VER.2 ON COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. THE FIRST SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.5 MG/DL AND IT REPEATED AS 3.12 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.7 MG/DL AND IT REPEATED AS 5.89 MG/DL. THE THIRD SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 1.6 MG/DL AND IT REPEATED AS 5.06 MG/DL. THE FOURTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.4 MG/DL AND IT REPEATED AS 4.13 MG/DL. THE FIFTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.4 MG/DL AND IT REPEATED AS 3.63 MG/DL. THE SIXTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.7 MG/DL AND IT REPEATED AS 4.81 MG/DL. THE SEVENTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 1.1 MG/DL AND IT REPEATED AS 5.48 MG/DL. THE EIGHTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 2.4 MG/DL AND IT REPEATED AS 4.2 MG/DL. THE NINTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.8 MG/DL AND IT REPEATED AS 4.2 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441703 UA2 URIC ACID TEST SYSTEM KNK ROCHE DIAGNOSTICS UA G2 66468501 07613336121580

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown