BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® PF PLUS

    MDR report key: 9011983 · Received September 12, 2019

    Report

    Report Number
    3002769706-2019-00060
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Report Date
    December 4, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357924
    PMA / PMN Number
    K183166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED FOR A CUSTOMER REPORT OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® PF PLUS CULTURE BOTTLES (REFERENCE (B)(4), LOT 4052885). BOTTLES FROM THREE PATIENTS WERE SUBCULTURED AND WERE POSITIVE AND IDENTIFIED AS ACIDOVORAX USING BRUKER MS. ALL ACIDOVORAX ISOLATES WERE ISOLATED FROM THE SAME WING AT THE HOSPITAL. THE INVESTIGATION EXAMINED THE BACT/ALERT® PF PLUS BOTTLE MANUFACTURING RECORDS FOR LOT 4052885 , THE COMPLAINT DATA, AND DIRECTIONS IN THE BOTTLE INSTRUCTIONS FOR USE [IFU]. NO EVIDENCE WAS FOUND TO SUPPORT THE ISOLATED ORGANISM ACIDOVORAX TEMPERANS WAS PRESENT IN THE SUSPECT LOT BEFORE RELEASE. A HISTORICAL REVIEW FOR DATE RANGE 16AUG18 THROUGH 03OCT19 OF ALL BACT/ALERT® BOTTLE COMPLAINTS WITH CONTAMINATION ERROR CODES DETERMINED THERE IS NO ADVERSE TREND FOR CONTAMINATION ISSUES. BACT/ALERT® PF PLUS LOT 4052885 HAS NO OTHER COMPLAINTS FOR CONTAMINATION AS OF 03OCT19. A REVIEW OF THE BOTTLE IFU PROVIDES SUFFICIENT INSTRUCTIONS ON THE INSPECTION OF BOTTLES BEFORE USE, THE BOTTLE PREPARATION PROCEDURE FOR BLOOD COLLECTION, AND THE IMPORTANCE OF AVOIDING CONTAMINATION OF THE CULTURE. AN INTERNAL REPORT PERFORMED IN 2019 THAT EXAMINED ALL INOCULATED BOTTLE CONTAMINATION COMPLAINTS FROM 10NOV18 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. DO NOT DRAW TEST TUBES PRIOR TO THE BLOOD CULTURE BOTTLES. 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.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF SUSPECTED CONTAMINATION RESULTS IN ASSOCIATION WITH BACT/ALERT® PF PLUS CULTURE BOTTLES (REFERENCE 410853, LOT 4052885). BOTTLES FROM THREE PATIENTS WERE SUBCULTURED AND WERE POSITIVE AND IDENTIFIED AS ACIDOVORAX USING BRUKER MS. ALL ACIDOVORAX ISOLATES WERE ISOLATED FROM THE SAME WING AT THE HOSPITAL. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808619 BACT/ALERT® PF PLUS BACT/ALERT® PF PLUS MDB BIOMERIEUX INC. 4052885 03573026357924

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention