BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACT/ALERT® 3D

    MDR report key: 6898368 · Received September 27, 2017

    Report

    Report Number
    1950204-2017-00317
    Event Type
    Death
    Date Received
    September 27, 2017
    Date of Event
    October 8, 2013
    Report Date
    December 21, 2017
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026049522
    PMA / PMN Number
    K903505
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: THE INSTRUMENT FUNCTIONED CORRECTLY, THE OBSERVA BACKUP SHOWS BOTTLE ID SPJ3FB06 FLAGGED POSITIVE. THE BOTTLE DETAIL SCREEN SHOWED AN UNCONFIRMED POSITIVE CHECK MARK, WHICH INDICATES THE POSITIVE BOTTLE WAS RELOADED. THE GRAPH DOES NOT HAVE ANY GAPS, WHICH INDICATES THE USER RE-LOADED IT IMMEDIATELY, POTENTIALLY BYPASSING PROTOCOLS FOR POSITIVE BOTTLES. THE IFU (PART# 9311988 REV. C) FOR PEDIATRIC CHARCOAL BOTTLES STATES TO 'SMEAR AND SUBCULTURE ALL POSITIVE BOTTLES. IF THE SMEAR IS NEGATIVE, INDICATING A POSSIBLE FALSE POSITIVE, THE BOTTLE SHOULD BE RELOADED INTO THE INSTRUMENT UNTIL GROWTH OF THE SUBCULTURE OR REDESIGNATION AS POSITIVE. BOTTLES THAT WERE INITIALLY DETERMINED FALSE POSITIVE AND WERE REDESIGNATED POSITIVE, SHOULD BE SMEARED AND SUBCULTURED.'

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH THE BACT/ALERT® UNIT. THE CUSTOMER REPORTED AN INITIAL BOTTLE ((B)(4)) WAS LOADED ON (B)(6) 2013 AND THE INSTRUMENT FLAGGED THE BOTTLE AS A NEGATIVE RESULT AFTER FIVE (5) DAYS ON (B)(6) 2013. AN ANALYSIS OF THE DATA INDICATES THIS BOTTLE WAS UNLOADED AS POSITIVE AT APPROXIMATELY 9 HRS., BUT RELOADED TO CONTINUE TESTING THROUGH THE FIVE (5) DAY PROTOCOL. A SECOND BOTTLE ((B)(4)) WAS LOADED ON (B)(6) 2013 AND THE INSTRUMENT FLAGGED THE BOTTLE AS POSITIVE AT 9.36 HOURS ON (B)(6) 2013. THE ORGANISM THAT GREW WAS IDENTIFIED AS KLEBSIELLA PNEUMONIAE. THE PATIENT IS A (B)(6) YEAR OLD FEMALE. THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. ON THE EVENING OF (B)(6) 2013, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT BECAUSE THE CAP HAD COME OFF OF HER PICC LINE, AND WAS NON-SYMPTOMATIC. A BLOOD DRAW WAS PERFORMED ON THE PATIENT AND SENT TO THE LABORATORY FOR TESTING. THE PATIENT HAD A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE FOR ADMINISTRATION OF NOURISHMENT. THE PATIENT DIED ON (B)(6) 2013. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676475 BACT/ALERT® 3D BACT/ALERT® 3D MDB BIOMERIEUX INC. 210147 03573026049522

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Death