BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID TM STAPH AUREUS AGAR

    MDR report key: 5072147 · Received September 11, 2015

    Report

    Report Number
    3002769706-2015-00083
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Report Date
    August 7, 2015
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    JWX
    PMA / PMN Number
    CL. I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS INITIATED. EVALUATION OF THE QC BATCH RECORDS FOR THE RELEASE OF CHROMID TM S AUREUS AGAR LOT 1004085400 INDICATES PERFORMANCE IN ACCORDANCE WITH SPECIFICATIONS AFTER 20 HOURS AND 24 HOURS OF INCUBATION AT 33-37 ° C. THIS LOT WAS THE SUBJECT OF STOP SHIPMENT ((B)(4), ISSUED 07AUG15) AND FIELD SAFETY CORRECTIVE ACTION (FSCA-2624, ISSUED 19AUG15) DUE TO INGREDIENT DISCREPANCY IN THE DRY ENVIRONMENT OF THE FORMULA USED IN THE MANUFACTURE OF THE LOT. THIS DISCREPANCY CAN INDUCE SLOWER OR WEAKER STAINING OF S. AUREUS STRAINS. CUSTOMERS WERE INSTRUCTED TO DISCARD THE INCRIMINATED PRODUCT LOT. A CAPA WAS INITIATED TO DETERMINE THE ROOT CAUSE OF THE RAW MATERIAL MIXTURE IN THE DRY ENVIRONMENT AND DEFINE THE CORRECTIVE AND PREVENTIVE ACTIONS. TESTING WAS PERFORMED ON THE AGAR PLATES SUBMITTED BY THE CLIENT. THREE (3) STAPHYLOCOCCUS AUREUS STRAINS WERE TESTED: ATCC 6538 AND 13150 GAVE CHARACTERISTIC COLONIES AT 24 HOURS, ATCC 25923 GAVE CHARACTERISTIC COLONIES AT 48 HOURS. THE ISSUE DESCRIBED BY THE CUSTOMER WAS NOT CONFIRMED WITH THE CHROMID S AUREUS PLATES SUBMITTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED INCONCLUSIVE RESULTS FOR THE STAPH AUREUS ATCC STRAIN (INDICATED IN THE INSTRUCTIONS FOR USE) IN ASSOCIATION WITH CHROMID TM STAPH AUREUS AGAR (REF. 43371, LOT 1004085400). THOUGH GREEN COLONIES ARE THE CORRECT INDICATION FOR A STAPH AUREUS ORGANISM, THE CUSTOMER CLAIMS THE OBSERVED LIGHT GREEN COLONY COLOR IS NOT TYPICAL COMPARED WITH THE OTHER LOT NUMBERS USED IN THE PAST. EVALUATION DURING THE TROUBLESHOOTING ACTIVITIES BY BIOMERIEUX SUPPORT DETERMINED THE REFERENCED LOT NUMBER WAS PLACED ON STOP ORDER BY BIOMERIEUX AND IS ASSOCIATED WITH A FIELD CORRECTIVE ACTION. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE INCONCLUSIVE RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. NO PATIENT WAS DIRECTLY ASSOCIATED WITH THE ATCC STRAIN RESULT. STRAIN SUBMITTALS HAVE BEEN REQUESTED BY BIOMERIEUX FOR INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601915 CHROMID TM STAPH AUREUS AGAR CHROMID STAPH AUREUS AGAR JWX BIOMÉRIEUX SA 1004085400

    Patients

    Seq Age Sex Outcome Treatment
    1