BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 2179678 · Received July 27, 2011

    Report

    Report Number
    1823260-2011-04028
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 14, 2011
    Report Date
    October 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    PMA / PMN Number
    K972250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE EVENT DETERMINED WATER ON TOP OF THE REACTION AREA DUE TO THE MISADJUSTED RINSE STATION AFFECTED THE ASSAY BY ADDITIONAL WATER DILUTION. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE BUN RESULT FOR ONE PATIENT SAMPLE FROM THE COBAS C501 ANALYZER SERIAL NUMBER (B)(4) THAT WAS DISCOVERED WHEN A DOCTOR QUESTIONED THE INITIAL RESULT REPORTED. THE INITIAL RESULT WAS 44 MMOL/L AND THE REPEAT RESULT ON ANOTHER COBAS C501 ANALYZER WAS 5 MMOL/L. THEN USER REFUSED TO PROVIDE FURTHER INFORMATION TO DETERMINE IF THE PATIENT WAS ADVERSELY AFFECTED. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THE RINSE ASSEMBLY WAS OUT OF ADJUSTMENT AND WAS CAUSING SPLASHING FROM THE CUVETTES. HE ADJUSTED THE RINSE ASSEMBLY AND TO VERIFY THE ANALYZER OPERATION, HE RAN SUCCESSFUL QUALITY CONTROL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1