BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® BPN EU

    MDR report key: 6170472 · Received December 13, 2016

    Report

    Report Number
    3002769706-2016-00509
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Report Date
    March 6, 2017
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MZC
    PMA / PMN Number
    BK050043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE CUSTOMER'S INITIAL TESTING WITH THE BACT/ALERT® BPN BOTTLE WAS PERFORMED BEFORE THE PLATELETS WERE SPLIT INTO TWO PACKS SHOWING A NEGATIVE RESULT. THE FIRST PACK WAS ADMINISTERED WITH NO ISSUES TO THE PATIENT. THE SECOND PACK AFTER TWO DAYS HAD A VISIBLE CLOT AND WHEN TESTED WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE SECOND PACK WITH THE VISIBLE CLOT IS INDICATIVE OF CONTAMINATION INTRODUCED WHEN THE PLATELETS WERE SPLIT INTO TWO PACKS. THE BACT/ALERT® BPN EU INSTRUCTIONS FOR USE WERE REVIEWED AND IT PROVIDES SUFFICIENT CAUTION TO THE USER ON PROPER HANDLING TECHNIQUE. GREAT CARE MUST BE TAKEN TO PREVENT CONTAMINATION OF THE PLATELET SAMPLE DURING INOCULATION INTO THE CULTURE BOTTLES. CONTAMINATION COULD LEAD TO A SPECIMEN BEING DETERMINED POSITIVE WHEN A CLINICALLY RELEVANT ISOLATE IS NOT ACTUALLY PRESENT IN THE DONATED PLATELET UNIT. THE INVESTIGATION EXAMINED THE BACT/ALERT® MANUFACTURING DIRECTIONS, INCLUDING THE QUALITY CONTROL RELEASE TESTING DOCUMENTATION, AND ALL RESULTS WERE WITHIN SPECIFICATION. THE INVESTIGATION DETERMINED THE MOST LIKELY ROOT CAUSE IS CONTAMINATION DURING THE DIVISION OF THE PLATELET SAMPLE. THE BACT/ALERT® BPN EU BOTTLES PERFORMED AS EXPECTED DURING INITIAL USE.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE (B)(6) REPORTED TO BIOMÉRIEUX A FALSE NEGATIVE FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH BACT/ALERT® BPN EU. A PLATELET UNIT WAS SAMPLED FOR CULTURE USING THE BACT/ALERT® SYSTEM AND WAS DETERMINED TO BE NEGATIVE AFTER 7 DAYS INCUBATION. THE SUBCULTURE WAS ALSO IDENTIFIED AS NEGATIVE. THE PLATELET UNIT WAS SPLIT INTO TWO SEPARATE PLATELET PACKS. ONE PACK WAS TRANSFUSED WITHOUT ANY NEGATIVE IMPACT TO THE PATIENT. TWO DAYS LATER, THE SECOND PACK WAS NOTICED TO HAVE "CLOTS" SO IT WAS CULTURED WITH BACT/ALERT® BPN EU AND WAS POSITIVE FOR STAPHYLOCOCCUS AUREUS AFTER 4 DAYS OF INCUBATION. THIS SECOND PLATELET PACK WAS NOT TRANSFUSED. THERE IS NO INDICATION THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. THE BOTTLE ID'S AND BACKUP DATA FROM THE INSTRUMENT'S 3D CONTROL MODULE HAVE BEEN REQUESTED FROM THE CUSTOMER. AN INTERNAL BIOMÉRIEUX HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821248 BACT/ALERT® BPN EU BACT/ALERT® BPN EU MZC BIOMERIEUX INC. 1046031

    Patients

    Seq Age Sex Outcome Treatment
    1