BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® BPA

    MDR report key: 6181870 · Received December 16, 2016

    Report

    Report Number
    3002769706-2016-00522
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Report Date
    March 6, 2017
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MZC
    PMA / PMN Number
    BK050037
    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 PERFORMED BEFORE THE PLATELETS WERE SPLIT INTO TWO PACKS SHOWED 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® BPA 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® BPA EU BOTTLES PERFORMED AS EXPECTED DURING INITIAL USE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT ASSOCIATED WITH THE BACT/ALERT® BPA CULTURE BOTTLE. THE CUSTOMER REPORTED PLATELETS WERE SCREENED USING THE BACT/ALERT® SYSTEM AND RECORDED NEGATIVE WITH THE BACT/ALERT® BPA AND BPN CULTURE BOTTLES AFTER SEVEN (7) DAYS OF INCUBATION AND ON TERMINAL SUBCULTURE. THE PLATELETS WERE HLA MATCHED FOR A PARTICULAR PATIENT AND WERE MADE INTO TWO (2) DOSES (AFTER BACTERIOLOGY TESTING). THE FIRST WAS TRANSFUSED WITHOUT EVENT BUT BEFORE THE SECOND WAS DUE TO BE TRANSFUSED (2 DAYS LATER), A PLATELET CLOT WAS NOTICED IN THE PACK. UPON RETESTING, THE PACK WAS FOUND TO CONTAIN STAPHYLOCOCCUS AUREUS AFTER ONLY FOUR (4) HOURS INCUBATION ON THE BACT/ALERT®. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830754 BACT/ALERT® BPA BACT/ALERT® BPA MZC BIOMERIEUX INC. 3046014

    Patients

    Seq Age Sex Outcome Treatment
    1