BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSITIVE COMBO 33

    MDR report key: 3812718 · Received April 25, 2014

    Report

    Report Number
    2919016-2014-00017
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 8, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THERE WAS NO TREATMENT FAILURE ASSOCIATED WITH THE INITIAL RESULTS REPORTED AND THE PATIENT HAS BEEN DISCHARGED. NO REPORT OF ADVERSE EVENT ASSOCIATED WITH THE DISCREPANT RESULTS.

    Description of Event or Problem · 1

    CUSTOMER TESTED TWO SPECIMENS AND BOTH RESULTED S. AEREUS SUSCEPTIBLE TO OXACILLIN AND CEFOXITIN SCREEN TEST. THIS RESULT WAS REPORTED TO THE PHYSICIAN. OFFLINE. OXACILLIN SCREEN AGAR WAS NONCONCLUSIVE. THE SPECIMEN WAS TESTED WITH THE COMPETITOR VITEK AND REPORTED AS OXACILLIN SUSCEPTIBLE. THE SPECIMEN WAS SENT TO THE REFERENCE LAB BY THE CUSTOMER AND REPORTED (B)(6) ON PCR MECA TEST. THE CUSTOMER NOTED THAT THERE WAS NO TREATMENT FAILURE ASSOCIATED WITH THE INITIAL RESULTS REPORTED AND THE PATIENT HAS SINCE BEEN DISCHARGED. THERE WAS NO CORRECTIVE RESULT SENT TO THE PHYSICIAN. TREATMENT WAS NOT DELAYED OR WITHHELD. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251104 POSITIVE COMBO 33 GRAM POSITIVE PANEL TYPE 33 LRG SIEMENS HEALTHCARE DIAGNOSTICS INC. 2015-01-21

    Patients

    Seq Age Sex Outcome Treatment
    1