BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 19840320 · Received July 26, 2024

    Report

    Report Number
    1823260-2024-02176
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 3, 2024
    Report Date
    September 5, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    UDI-DI
    04015630925131
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ALP2 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 AND UREAL UREA/BUN RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. THIS MEDWATCH WILL COVER UREA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ALP2 RESULTS. FOR SAMPLE 1, THE INITIAL ALP RESULT WAS 9 U/L. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 144 U/L. FOR SAMPLE 2, THE INITIAL UREA RESULT WAS 0.5 MMOL/L. THE RESULT WAS LOWER THAN THE MEASURING RANGE WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 11.6 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934281 UREA/BUN UREA NITROGEN TEST SYSTEM CDQ ROCHE DIAGNOSTICS ASKU 04015630925131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown