BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UA2

    MDR report key: 16781472 · Received April 20, 2023

    Report

    Report Number
    1823260-2023-01351
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 28, 2023
    Report Date
    June 9, 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
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT RESULTS WERE PROVIDED ON 27-APR-2023. ON (B)(6) 2023, THE PATIENT HAD A URIC ACID RESULT OF 4.2 MG/DL. ON (B)(6) 2023, THE PATIENT HAD A URIC ACID RESULT OF 4.7 MG/DL. ON (B)(6) 2023, THE PATIENT HAD A URIC ACID RESULT OF 2.0 MG/DL. ON (B)(6) 2023, THE PATIENT HAD A URIC ACID RESULT OF 1.8 MG/DL. ON (B)(6) 2023, THE PATIENT HAD A URIC ACID RESULT OF 1.6 MG/DL. ON (B)(6) 2023, THE PATIENT HAD A URIC ACID RESULT OF 1.8 MG/DL. ON (B)(6) 2023, THE PATIENT HAD A URIC ACID RESULT OF 1.6 MG/DL. ON (B)(6) 2023, THE PATIENT HAD A URIC ACID RESULT OF 1.8 MG/DL. ON (B)(6) 2023, THE PATIENT HAD A URIC ACID RESULT OF 1.7 MG/DL. ON (B)(6) 2023, THE PATIENT HAD A URIC ACID RESULT OF 1.4 MG/DL. ON (B)(6) 2023, THE PATIENT HAD A URIC ACID RESULT OF 1.5 MG/DL. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CALIBRATION AND QC DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    IT WAS FOUND THAT THE PATIENT TAKES THE MEDICATION FASTURTEC WHICH CAN CAUSE THE DEGRADATION OF URIC ACID AND LEAD TO FALSELY LOW RESULTS. THE DRUG MANUFACTURER INDICATES THAT SAMPLES COLLECTED FROM PATIENTS RECEIVING THIS MEDICATION MUST UNDERGO A SPECIFIC PRE-ANALYTICAL PREPARATION. THIS PREPARATION INCLUDES COOLING THE SAMPLE AFTER COLLECTION AND DURING CENTRIFUGATION. THE CAUSE OF THE EVENT WAS DETERMINED TO BE A PRE-ANALYTICAL SAMPLE HANDLING ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE UA2 URIC ACID VER.2 RESULTS FOR 1 PATIENT FROM 5 SAMPLES ON TWO COBAS 8000 COBAS C 502 MODULES, SERIAL NUMBERS (B)(6). THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER COMMUNICATED WITH THE DOCTOR AND THEY STATED THAT THE RESULTS DO NOT MATCH THE PATIENT'S CLINICAL STATUS AND AN INTERFERING SUBSTANCE IS SUSPECTED. ON (B)(6)2023, THE UA2 RESULT FROM ANALYZER 17E4-01 WAS 0.0 MG/DL. THE SAMPLE WAS REPEATED ON ANALYZER 17E4-02 AND THE RESULT WAS 0.0 MG/DL. A SECOND SAMPLE COLLECTED FROM THE PATIENT ON (B)(6) 2023 ALSO RESULTED IN A UA VALUE OF 0.0 MG/DL ON ANALYZER 17E4-01. ON (B)(6) 2023, THE UA2 RESULTS FROM ANALYZER 17E4-01 WERE 0.1 MG/DL AND 0.1 MG/DL. THE SAMPLE WAS REPEATED ON ANALYZER 17E4-02 AND THE RESULT WAS 0.1 MG/DL. ON (B)(6) 2023, THE UA2 RESULT FROM ANALYZER 17E4-02 WAS 1.3 MG/DL. ON (B)(6) 2023, THE UA2 RESULT FROM ANALYZER 17E4-02 WAS 2.7 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1613667 UA2 URIC ACID TEST SYSTEM KNK ROCHE DIAGNOSTICS NA 693815 04015630919154

    Patients

    Seq Age Sex Outcome Treatment
    1 Male ATENOLOL| CYKLOKAPRON| FASTUREC| LYRICA| NOVALGIN| VITAMIN K