BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANCOMYCIN

    MDR report key: 2181633 · Received July 27, 2011

    Report

    Report Number
    1823260-2011-04044
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LEH
    PMA / PMN Number
    K060586
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE RESULT FOR VANCOMYCIN ON THEIR COBAS C501 (SERIAL NUMBER (B)(4)). THE CUSTOMER PROVIDED RESULTS FOR ONE DISCREPANT RESULT REPORTED OUTSIDE THE LABORATORY. REPEAT TESTING WAS PERFORMED ON THE SAME C501 ANALYZER. THE PATIENT'S INITIAL VANCOMYCIN RESULT WAS 1.0 UG/ML ACCOMPANIED BY A DATA FLAG. THE FIRST REPEAT RESULT WAS 18.2 UG/ML. THE SECOND REPEAT RESULT WAS 18.4 UG/ML. THE CUSTOMER BELIEVED THE 18.4 UG/ML RESULT WAS CORRECT AND ISSUED IT AS A CORRECTED REPORT. THERE WERE NO ADVERSE AFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT. THE CUSTOMER DETERMINED THE CAUSE OF THE EVENT WAS A SAMPLE HANDLING ISSUE DUE TO GEL ON THE SAMPLE TUBES. THE CUSTOMER MONITORS SAMPLES PRIOR TO RUNNING AND NO LONGER HAS ISSUES. THE CUSTOMER STATES THE SAMPLES ARE REPORTING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANCOMYCIN RADIOIMMUNOASSAY, VANCOMYCIN LEH ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1