BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY TEST CARD (AST-GP67)

    MDR report key: 3231834 · Received November 12, 2012

    Report

    Report Number
    1950204-2012-00004
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K050002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING INFO REGARDING THE REPORTED INCIDENT: A FALSE RESISTANT RESULT FOR TRIMETHOPRIM/SULFAMETHOXAZOLE (SXT) REGARDING A STAPHYLOCOCCUS AUREUS (SA) SAMPLE WITH THE VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY CARD (AST-GP67). THE RESULTS INDICATED THAT THE SAMPLE WAS RESISTANT TO TRIMETHOPRIM/SULFAMETHOXAZOLE (SXT), WHICH LED THE TREATING PHYSICIAN TO DISCONTINUE PREVIOUSLY PRESCRIBED SXT THERAPY. UPON DISCONTINUATION OF SXT THERAPY, THE PT WAS TREATED WITH MOXIFLOXACIN. THE PT SAMPLE WAS SENT TO A REFERENCE LAB FOR ADDITIONAL TESTING AND CONFIRMATION OF THE INITIAL RESISTANT RESULT. THE ADDITIONAL TESTING CONFIRMED THAT THE PT SAMPLE WAS SENSITIVE/SUSCEPTIBLE TO SXT. BASED ON THE RESULTS FROM THE REFERENCE LAB, THE TREATING PHYSICIAN PRESCRIBED SXT THERAPY TO THE PT. THERE WAS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE FALSE RESISTANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PT STATE OF HEALTH. THERE WAS NO INFO AVAILABLE TO CLEARLY SEPARATE THE FALSE RESISTANT RESULT FROM THE DISCONTINUATION OF SXT THERAPY. THIS EVENT IS BEING REPORTED SINCE TREATMENT INTERVENTION WAS IMPACTED IN ASSOCIATION WITH A FALSE RESISTANT RESULT. A REVIEW OF THE BATCH RECORD AND QC TESTING RESULTS FOR VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY (AST-GP67) CARD, LOT NUMBER 132254242, BY BIOMERIEUX, DID NOT REVEAL ANY ABNORMALITIES OR INDICATORS OF PRODUCT NON-CONFORMITY. THERE WERE NO DISCREPANCIES IN THE QC RELEASE DATA AND THE RESULTS WERE WITHIN THE IDENTIFIED SPECIFICATIONS. REVIEW OF THE COMPLAINT TRENDING INDICATES THAT THERE HAVE BEEN NO OTHER COMPLAINTS REGARDING FALSE RESISTANT RESULTS ASSOCIATED WITH SXT FOR THE VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY AST-GP67 CARD (LOT NUMBER 132254242). THE FALSE RESISTANT RATE OBSERVED ON THE IDENTIFIED LOT DOES NOT FALL OUTSIDE THE DECLARED PERFORMANCE. THE OVERALL COMPLAINT DATA AND COMPLAINT INVESTIGATION DOES NOT SUGGEST THERE IS AN ISSUE ASSOCIATED WITH SXT PERFORMANCE IN THE LOT REFERENCED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY TEST CARD (AST-GP67) VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY TEST CARD LON BIOMERIEUX, INC. 132254242

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention