BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FA PLUS

    MDR report key: 8947129 · Received August 29, 2019

    Report

    Report Number
    3002769706-2019-00056
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Report Date
    December 4, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357900
    PMA / PMN Number
    K121461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN AUSTRALIA REGARDING SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® FA PLUS CULTURE BOTTLES (REFERENCE (B)(4), LOT 4052897). BOTTLES FROM THREE PATIENTS, OVER A PERIOD OF ONE MONTH, WERE POSITIVE FOR CANDIDA ALBICANS AND CANDIDA PARAPSILOSIS COMPLEX. ONE OF THE PATIENTS WAS CONFIRMED FOR CANDIDA SPECIES; THE OTHER TWO PATIENTS HAD A FALSE DETECTION. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE INVESTIGATION EXAMINED THE MANUFACTURING RECORDS FOR BACT/ALERT FA PLUS LOT 4052897, THE ASSOCIATED COMPLAINT DATA, AND THE INSTRUCTIONS FOR USE [IFU]. NO ADVERSE TREND IS PRESENT IN THE COMPLAINT DATA FOR INOCULATED BOTTLE CONTAMINATION WITH CANDIDA SPECIES. THE BOTTLE IFU CONTAINS SUFFICIENT DIRECTIONS FOR CLEANING THE BOTTLE STOPPER, AND AVOIDANCE OF CONTAMINATING THE BOTTLE DURING INOCULATION. NO EVIDENCE WAS FOUND IN THE MANUFACTURING RECORD REVIEW TO SHOW A PROBLEM WITH CONTAMINATION OF BOTTLES, OR THE PRESENCE OF CANDIDA SPECIES BEFORE RELEASE. THE BATCH MET ALL RELEASE CRITERIA AND QUALITY ASSURANCE SUBSEQUENTLY RELEASED THE LOTS FOR DISTRIBUTION TO THE FIELD. INTERNAL REPORTS PERFORMED IN 2018 AND 2019 THAT EXAMINED ALL INOCULATED BOTTLE CONTAMINATION COMPLAINTS FROM 01JAN18 THROUGH 07AUG19 FOR BACT/ALERT® CULTURE BOTTLES DETERMINED THAT THE BOTTLES WERE NOT THE LIKELY SOURCE FOR THESE COMPLAINTS. THERE IS NO EVIDENCE FOUND AT THE TIME OF THIS INVESTIGATION, THAT THE SOURCE FOR THIS CUSTOMER'S COMPLAINT IS CONTAMINATION OF THE BOTTLE BY THE MANUFACTURER PRIOR TO USE BY THE CUSTOMER. GLOBAL CUSTOMER SERVICE ADVISES TO FOLLOW THE DIRECTIONS IN THE IFU, AND TO CLEAN THE BOTTLE STOPPER WITH ONE DISINFECTANT WIPE PER BOTTLE TOP AND ALLOW TO AIR DRY. THE BOTTLE STOPPER IS NOT STERILE UNDER THE PLASTIC FLIP CAP, AS THE FLIP CAP IS NOT AIR TIGHT. FURTHER ACTIONS THE CUSTOMER CAN TAKE ARE TO: REVIEW THEIR BLOOD CULTURE COLLECTION PROCEDURE, TO ENSURE IT IS ADEQUATE FOR SITE DISINFECTION CONSIDER RETRAINING TO ENSURE STAFF ARE FOLLOWING PROCEDURES ALWAYS DRAW THE BOTTLES BEFORE ANY TEST TUBES PERFORM INTERNAL INVESTIGATION TO ENSURE NO ONE LOCATION OR PHLEBOTOMIST IS CONTRIBUTING; AND THAT NO OTHER SOURCE COULD BE CONTRIBUTING SUCH AS, GLOVES, HAND SANITIZERS, DISINFECTANT WIPES, IV SOLUTIONS/DRUGS. THERE IS NOT ENOUGH INFORMATION PROVIDED BY THE CUSTOMER TO CATEGORICALLY DETERMINE THE ROOT CAUSE FOR THIS INCIDENT. BASED ON THE INFORMATION PROVIDED, THE MOST PROBABLE ROOT CAUSE IS CONTAMINATION DURING INOCULATION AND/OR SUBCULTURE. CANDIDA SPECIES ARE FUNGAL ORGANISMS, COMMENSAL TO THE HUMAN SKIN. AS SUCH, THEY DO NOT FORM SPORES AND THEREFORE ARE NOT LIKELY BOTTLE MANUFACTURING CONTAMINANTS AS THEY ARE EASILY KILLED DURING TERMINAL STERILIZATION (VIA AUTOCLAVE). THE INVESTIGATION CONCLUDED THE CONTAMINANT WAS INTRODUCED AT THE TIME OF BOTTLE INOCULATION BY THE USER.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® FA PLUS CULTURE BOTTLES (REFERENCE 410851, LOT 4052897). THE BOTTLES WERE SUBCULTURED AND IDENTIFIED CANDIDA ALBICANS AND CANDIDA PARAPSILOSIS COMPLEX. ALL CANDIDA ISOLATES WERE ISOLATED AT THE SAME HOSPITAL. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARMED OR TREATED INCORRECTLY DUE TO THE DISCREPANT RESULT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738454 BACT/ALERT® FA PLUS BACT/ALERT® FA PLUS MDB BIOMERIEUX INC. 4052897 03573026357900

    Patients

    Seq Age Sex Outcome Treatment
    1