BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL BILIRUBIN SPECIAL

    MDR report key: 2112756 · Received June 3, 2011

    Report

    Report Number
    1823260-2011-02990
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIG
    PMA / PMN Number
    K063543
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. BASED UPON INFORMATION PROVIDED, THE MOST LIKELY CAUSE OF THE LOW SECOND RESULT WAS A SAMPLE PIPETTING PROBLEM. NO ADVERSE EVENTS WERE REPORTED IN THIS CASE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY RECEIVED A QUESTIONABLE TOTAL BILIRUBIN (T BILI) RESULT ON THEIR COBAS C501 ANALYZER (SERIAL NUMBER (B)(4)). THE PATIENT, (B)(6), HAD AN INITIAL T BILI RESULT OF 15.7 MG/DL ACCOMPANIED BY A DATA FLAG. THE ANALYZER PERFORMED AN AUTO-RERUN AND THE RESULT WAS 5.0 MG/DL. THE RERUN RESULT WAS REPORTED OUTSIDE THE LABORATORY AND CONSIDERED TO BE ERRONEOUS. TWO TO THREE HOURS LATER, THE PATIENT HAD A REDRAW SAMPLE ANALYZED AND THE RESULT WAS 16.9 MG/DL. THE REDRAW SAMPLE IS CONSIDERED TO BE CORRECT AND WAS ISSUED ON A CORRECTED REPORT. THERE WERE NO ADVERSE AFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE THE CAUSE OF THE EVENT. HE PERFORMED INSTRUMENT CHECKS WITH PASSING RESULTS. THE CUSTOMER RAN QUALITY CONTROLS AND THE RESULTS WERE TO THEIR SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL BILIRUBIN SPECIAL DIAZO COLORIMETRY, BILIRUBIN CIG ROCHE DIAGNOSTICS NA 64041101

    Patients

    Seq Age Sex Outcome Treatment
    1