BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 22707790 · Received August 4, 2025

    Report

    Report Number
    1823260-2025-02388
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 10, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    UDI-DI
    04015630920464
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025, AND IT SHOWED "STD E" ALARMS. THE QC RECOVERY WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE CENTRIFUGE TIME WAS SHORT, AND THE SPEED WAS HIGH. THE SERVICE ACTIONS PERFORMED BY THE FIELD SERVICE ENGINEER RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS DUE TO A USER ERROR WHERE THE DEIONIZED WATER CALIBRATOR HAD BEEN CHANGED, CAUSING AN ASSAY SHIFT.

    Additional Manufacturer Narrative · 0

    THE UREAL REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE C311 STAND ALONE SYSTEM SERIAL NUMBER WAS (B)((6). THE FIELD SERVICE ENGINEER (FSE) CHECKED THE INSTRUMENT AND FOUND THAT THE DEIONIZED WATER CALIBRATOR HAD BEEN CHANGED, CAUSING AN ASSAY SHIFT. HE VERIFIED THAT THE ASSAY PARAMETER WAS CORRECT AND THE DEIONIZED WATER CALIBRATOR WAS CORRECTLY INSTALLED. THE FSE INSTRUCTED THE CUSTOMER TO LOAD A NEW REAGENT PACK AND PERFORM CALIBRATION. AFTERWARD, CALIBRATION AND QC WERE WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH UREA/BUN (UREAL) ASSAY ON A COBAS 4000 C311 STAND ALONE SYSTEM. INITIAL RESULT: 244 MG/DL (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: 228 MG/DL (AUTO-REPEATED WITH DILUTION). 2ND REPEAT RESULT: 25 MG/DL. THE 2ND REPEAT RESULT WAS DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277184 UREA/BUN UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN CDQ ROCHE DIAGNOSTICS ASKU 04015630920464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown