BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 21217740 · Received January 23, 2025

    Report

    Report Number
    1823260-2025-00208
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    January 3, 2025
    Report Date
    February 4, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    UDI-DI
    04015630925131
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER FOUND CRYSTALS FORMED ON THE CUVETTES. THE CUVETTES WERE REPLACED AND THE CUVETTE SURFACE WAS CLEANED. PRECISION TESTING WAS PERFORMED AND WAS WITHIN SPECIFICATIONS. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO THE HUMIDITY LEVEL IN THE LAB WHICH CAN CAUSE CRYSTALS OF ECOTERGENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE COBAS 8000 C702 MODULE SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER REPLACED THE CUVETTES, WHICH APPEARED TO RESOLVE THE ISSUE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE UREA/BUN RESULTS FROM THE COBAS 8000 C702 MODULE. SAMPLE 1 INITIAL RESULT WAS 9.06 MMOL/L THE REPEAT RESULTS WERE 35.84 MMOL/L AND 35.72 MMOL/L. ON (B)(6) 2024, SAMPLE 2 INITIAL RESULT WAS 0.85 MMOL/L. THE REPEAT RESULTS WERE 14.61 MMOL/L AND 14.67 MMOL/L. THE FINAL REPEAT RESULTS WERE BELIEVED CORRECT AND WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421234 UREA/BUN UREA NITROGEN TEST SYSTEM CDQ ROCHE DIAGNOSTICS 832104 04015630925131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown