BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1032777 · Received April 23, 2008

    Report

    Report Number
    1823260-2008-03483
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 19, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE WITH DISCREPANT VANCOMYCIN RESULTS. INITIAL RESULT GAVE 1.1 UG/ML; SAME SAMPLE REPEATED GAVE 1.0 UG/ML. ON 03/25/08, SAME SAMPLE WAS REPEATED RESULTING AT 18.7 UG/ML. IN RESPONSE TO THE INITIAL RESULTS REPORTED PT'S VANCOMYCIN DOSAGE WAS INCREASED. ANOTHER SAMPLE WAS OBTAINED FROM THE PT, AND WAS ANALYZED BY AN UNKNOWN METHOD WHICH GAVE A VANCOMYCIN RESULT OF 33 UG/ML. THE PT'S SERUM CREATININE AND BUN WERE SLIGHTLY ELEVATED FOLLOWING THE INCREASED VANCOMYCIN DOSE. HOWEVER, THE CREATININE AND BUN VALES HAVE RETURNED TO NORMAL LEVELS INDICATING NO PERSISTENT ADVERSE EFFECTS. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE DISCREPANCY. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other