BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID® STAPH AUREUS

    MDR report key: 5924147 · Received September 2, 2016

    Report

    Report Number
    3002769706-2016-00162
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Report Date
    August 8, 2016
    Manufacturer
    BIOMÉRIEUX ESPAÑA
    Product Code
    JWX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO A FALSE NEGATIVE EVENT WHILE USING THE CHROMID® STAPH AUREUS PLATES WAS PERFORMED. THE CHROMID® STAPH AUREUS FAILED TO GROW A QC-STRAIN ON MULTIPLE ATTEMPTS. A COMPLAINT TREND REVIEW WAS PERFORMED ON THIS LOT. NO OTHER SIMILAR COMPLAINTS HAVE BEEN RECEIVED. FOUR ATCC® QUALITY CONTROL SAMPLES (ATCC® 2593, ATCC® 6538, ATCC® 29971, AND ATCC® 15305) WERE INOCULATED ONTO RETAIN PLATES FROM THE IMPLICATED LOT AS WELL AS 4 LOTS FROM VARYING EXPIRY DATING, SIMILAR TO IMPLICATED PLATES, AT EXPIRY, MIDDLE OF SHELF-LIFE, AND FRESHLY MANUFACTURED. ADDITIONALLY, CUSTOMER RETURNED SAMPLES WERE INOCULATED WITH THE SAME ATCC® QUALITY CONTROL SAMPLES. ALL PLATES INOCULATED GREW THE ORGANISM AS EXPECTED. BASED ON THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AND THE PRODUCT IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BIOMERIEUX A DISCREPANT RESULT EVENT OCCURRED WHEN USING THE CHROMID® STAPH AUREUS PLATE. THE CUSTOMER REPORTED THAT A QUALITY CONTROL SAMPLE FAILED TO GROW ON THE CHROMID® STAPH AUREUS PLATE. THE CUSTOMER DID REPEAT THE QUALITY CONTROL SAMPLE TWICE WITH THE SAME RESULTS OF NO GROWTH OBSERVED. SINCE THE INCIDENT INVOLVED QUALITY CONTROL SAMPLES AND NOT PATIENT SAMPLES, NO ADVERSE IMPACT TO THE PATIENT OR DELAY IN RESULTS WAS EXPERIENCED. AN INVESTIGATION HAS BEEN INITIATED BY BIOMERIEUX TO INVESTIGATE THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577314 CHROMID® STAPH AUREUS CHROMID® STAPH AUREUS JWX BIOMÉRIEUX ESPAÑA 1004942170

    Patients

    Seq Age Sex Outcome Treatment
    1