BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 24930868 · Received April 20, 2026

    Report

    Report Number
    1823260-2026-01502
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    UDI-DI
    04015630925131
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND CONTROL RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. THE ALARM TRACE SHOWED ABNORMAL CELL BLANK, LOW PRESSURE IN THE VACUUM TANK, AND SAMPLE SHORT ALARMS. THE FIELD SERVICE ENGINEER (FSE) CHECKED THE SAMPLE AND REAGENT PROBES, GEAR PUMP PRESSURES, AND RINSE VOLUMES, AND PERFORMED A MECHANICAL CHECK SUCCESSFULLY. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT. 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 LOW UREA/BUN RESULTS FOR 3 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. SAMPLE 1 HAD AN INITIAL RESULT OF 1.2 MG/DL. THE SAMPLE WAS REPEATED ON A SIEMENS ANALYZER AND THE RESULT WAS 41 MG/DL. SAMPLE 2 HAD AN INITIAL RESULT OF 1.8 MG/DL. THE SAMPLE WAS REPEATED ON A SIEMENS ANALYZER AND THE RESULT WAS 28 MG/DL. SAMPLE 3 HAD AN INITIAL RESULT OF 2.6 MG/DL. THE SAMPLE WAS REPEATED ON A SIEMENS ANALYZER AND THE RESULT WAS 62 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404988 UREA/BUN UREA NITROGEN TEST SYSTEM CDQ ROCHE DIAGNOSTICS 89811001 04015630925131

    Patients

    Seq Age Sex Outcome Treatment
    1