BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P580 TEST KIT

    MDR report key: 8550779 · Received April 25, 2019

    Report

    Report Number
    1950204-2019-00105
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Report Date
    July 10, 2019
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE CEFOXITIN SCREEN RESULTS ASSOCIATED WITH VITEK® 2 AST-P580 TEST KIT (REFERENCE 22233, LOT 3600753403). IN RESPONSE TO THE CUSTOMER COMPLAINT, BIOMÉRIEUX PERFORMED AN INTERNAL INVESTIGATION. THE CUSTOMER DID NOT SUBMIT THEIR ISOLATES OR LAB REPORTS TO BIOMÉRIEUX; THEREFORE, THE CUSTOMER'S TEST DISCREPANCY COULD NOT BE COMPARED TO THE REFERENCE METHOD FOR THIS INVESTIGATION. A REVIEW OF BIOMÉRIEUX MANUFACTURING BATCH RECORDS FOR VITEK® 2 AST-P580 TEST KIT LOT 3600753403 SHOWED THAT THIS LOT MET ALL FINAL QC RELEASE CRITERIA. NONCONFORMANCE MANUFACTURING RECORDS (NCMRS) WERE REVIEWED FROM 04-MAY-2018 TO 04-JUN-2019, NO NCMRS WERE WRITTEN FOR THE AST-P580 CARD. CUSTOMER SERVICE PERFORMED A SEARCH FOR ALL COMPLAINTS AGAINST AST-P580 CARD LOT 3600753403. THE REVIEW OF THE COMPLAINTS DID NOT INDICATE A TREND FOR THIS CARD LOT.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE POSITIVE CEFOXITIN SCREEN (OXSF) RESULT FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH THE VITEK® 2 AST-P580 TEST KIT. ALTERNATE METHOD TESTING BY DISK DIFFUSION PROVIDED A NEGATIVE RESULT (27MM). NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS REQUESTED ADDITIONAL DETAIL FROM THE CUSTOMER. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341703 VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P580 TEST KIT VITEK® 2 AST-P580 CARD LON BIOMERIEUX, INC 3600753403

    Patients

    Seq Age Sex Outcome Treatment
    1