BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 25219421 · Received May 19, 2026

    Report

    Report Number
    1823260-2026-01967
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    UDI-DI
    04015630925131
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBERS OF THE ANALYZERS ARE: MODULE 1 - (B)(6), MODULE 2 - (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE UREA/BUN ASSAY RESULTS FOR THREE PATIENT SAMPLES TESTED ON TWO COBAS 8000 C 701 MODULES (MODULE 1, MODULE 2) ONE PATIENT SAMPLE WAS IDENTIFIED TO HAVE DISCREPANT RESULTS: THE INITIAL RESULT FROM MODULE 1 WAS 3.8 MG/DL, ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT FROM MODULE 2 WAS 53.1 MG/DL. THE INITIAL RESULT WAS DEEMED IMPLAUSIBLE AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602940 UREA/BUN UREA NITROGEN TEST SYSTEM CDQ ROCHE DIAGNOSTICS 939767 04015630925131

    Patients

    Seq Age Sex Outcome Treatment
    1