BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANCOMYCIN

    MDR report key: 2112403 · Received June 3, 2011

    Report

    Report Number
    1823260-2011-02987
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 3, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LEH
    PMA / PMN Number
    K954992
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THE SAME DATA WAS REPORTED FOR COBAS INTEGRA 400 ANALYZER (B)(4) IN THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

    Description of Event or Problem · 1

    THE USER DISCOVERED QUESTIONABLE VANCOMYCIN RESULTS FOR TWO PATIENT SAMPLES FROM THE COBAS INTEGRA 400 ANALYZER (B)(4) AFTER THE RESULTS WERE QUESTIONED BY A PHARMACIST. OF THE DATA PROVIDED, THE RESULTS FOR ONE SAMPLE WERE DISCREPANT. THE RESULT FROM COBAS INTEGRA 400 ANALYZER (B)(4) WAS 32.4 UG/ML. THE RESULT FROM COBAS INTEGRA 400 ANALYZER (B)(4) WAS 34.7 UG/ML. THE RESULT FROM A SISTER LAB USING A SIEMEN VISTA ANALYZER ON (B)(6) 2011 WAS 24.7 UG/ML. THE RESULT OF 32.4 UG/ML WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE USER DECLINED A SERVICE VISIT AS SHE BELIEVED THE INTEGRA RESULTS TO BE ACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANCOMYCIN RADIOIMMUNOASSAY, VANCOMYCIN LEH ROCHE DIAGNOSTICS NA 63035501

    Patients

    Seq Age Sex Outcome Treatment
    1