BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANCOMYCIN TEST SYSTEM

    MDR report key: 2136341 · Received December 18, 2007

    Report

    Report Number
    1836010-2007-00001
    Event Type
    Malfunction
    Date Received
    December 18, 2007
    Report Date
    December 14, 2007
    Manufacturer
    SERADYN
    Product Code
    LEH
    PMA / PMN Number
    K050419
    Removal / Correction Number
    1836010-12/14/07-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSSIBLE FALSE NEGATIVE RESULT ON PT RESULTS. CUSTOMER STATED THAT A PT ON VANCOMYCIN TREATMENT TESTED BELOW THE LOQ (2.5 M/ML) WHEN TESTED ON OMS VANCOMYCIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANCOMYCIN TEST SYSTEM QMS VANCOMYCIN LEH SERADYN 0373589 700657

    Patients

    Seq Age Sex Outcome Treatment
    1