BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® SA BOTTLE

    MDR report key: 6440226 · Received March 28, 2017

    Report

    Report Number
    3002769706-2017-00055
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Report Date
    July 10, 2017
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    MDB
    PMA / PMN Number
    K020931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A PROBLEM WITH DUPLICATE BAR CODES ASSOCIATED WITH BACT/ALERT® SA BOTTLES. AN INVESTIGATION WAS PERFORMED. THE INVESTIGATION EXAMINED THE BACT/ALERT® MANUFACTURING DIRECTIONS, INCLUDING THE QUALITY CONTROL RELEASE TESTING DOCUMENTATION, AND ALL RESULTS WERE WITHIN SPECIFICATION. BASED UPON THE CUSTOMER INTERACTION AND BIOMÉRIEUX INTERNAL FINDINGS, THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS) IS THE ROOT CAUSE OF THIS INVESTIGATION. SINCE ALL BOTTLE IDS ARE RETAINED IN MEMORY INDEFINITELY, AND BOTTLE ID NUMBERS ARE FINITE, A DUPLICATION OF BOTTLE ID WILL EVENTUALLY OCCUR. THE CURRENT WORKFLOW OF USING A GENERIC BOTTLE BARCODE LABEL ON BOTTLES RECOGNIZED AS DUPLICATE SHOULD BE CONTINUED. BIOMÉRIEUX RECOMMENDS A PURGE OF BOTTLE IDS FROM THE LIS DATABASE WITH MORE THAN A PREDETERMINED NUMBER OF DAYS OF BEING UNLOADED BASED ON CUSTOMER NEEDS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A PROBLEM WITH DUPLICATE BAR CODES ASSOCIATED WITH BACT/ALERT® SA BOTTLES. THE CUSTOMER REPORTED THAT BEFORE A BLOOD SAMPLE IS COLLECTED, THE SA BOTTLE ID IS SCANNED INTO THE LIS SYSTEM. WHEN SA BOTTLE LOT 1046662 IS SCANNED, THE SYSTEM SHOWS THE BOTTLE ID HAS ALREADY BEEN RECORDED FOR YEAR 2015. WHEN A BOTTLE ID IS DUPLICATED, THE UNUSED BOTTLE IS DISCARDED AND A NEW BOTTLE USED. THE CUSTOMER REPORTED THERE IS NO IMPACT ON PATIENTS, AS THE CUSTOMER DISCARDS THE UNUSED BOTTLES WHEN THE LIS GIVES NOTIFICATION THAT THE BOTTLE ID HAS BEEN USED BEFORE. THE CUSTOMER WAS INSTRUCTED TO USE A GENERIC BOTTLE ID LABEL TO ALLOW BOTTLE LOADING INTO THE LIS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222444 BACT/ALERT® SA BOTTLE BACT/ALERT® SA BOTTLE MDB BIOMERIEUX, INC. 1046662

    Patients

    Seq Age Sex Outcome Treatment
    1