BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 2122887 · Received June 14, 2011

    Report

    Report Number
    1823260-2011-03239
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 28, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    PMA / PMN Number
    K972250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY WERE RECEIVING QUESTIONABLE RESULTS FOR BUN ON THEIR COBAS C501 ANALYZER ((B)(4)). THE CUSTOMER PROVIDED DATA FOR FOUR PATIENTS OF WHICH THERE WAS ONE DISCREPANT RESULT THAT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S INITIAL BUN RESULT WAS 41.7 MG/DL ACCOMPANIED BY A DATA FLAG. THE FIRST REPEAT TEST WAS RUN ON A DECREASED SAMPLE VOLUME. THE RESULT WAS 43.4 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE SECOND REPEAT TEST WAS PERFORMED ON ANOTHER C501 ((B)(4)). THE RESULT WAS 27.5 MG/DL AND WAS ISSUED AS A CORRECTED REPORT. NO ACTION WAS TAKEN BASED ON THE ORIGINAL RESULT AND THERE WAS NO ALLEGATION OF SERIOUS INJURY OR DEATH. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE OF THE EVENT WAS A DEFECTIVE LIGHT PATH. HE REPLACED THE LAMP AND CELLS. FOR VERIFICATION, HE RAN A PRECISION CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UREA/BUN UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN CDQ ROCHE DIAGNOSTICS NA 63978401

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR