BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® SN CULTURE BOTTLE

    MDR report key: 7796958 · Received August 20, 2018

    Report

    Report Number
    3002769706-2018-00152
    Event Type
    Malfunction
    Date Received
    August 20, 2018
    Report Date
    March 12, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026055813
    PMA / PMN Number
    K021123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN THE UNITED STATES REGARDING DISCREPANT RESULTS ASSOCIATED WITH BACT/ALERT® SN CULTURE BOTTLE (REFERENCE 259790). THE CUSTOMER REPORTED DURING AN API STUDY THEY INOCULATED A BACT/ALERT SN AND A BACT/ALERT SA CULTURE BOTTLE. BOTH BOTTLES REPORTED POSITIVE IN THREE (3) DAYS FOR BACILLUS SPECIES. RESULTS FOR THE STUDY WERE REPORTED AS BACILLUS; HOWEVER THE CUSTOMER EXPECTED A DIFFERENT ORGANISM THAT WAS ANAEROBIC. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. ON 27JUL18 THE CUSTOMER CONTACTED LEVEL 1 CUSTOMER SERVICE TO SAY THEY HAD A DISCREPANT RESULT WITH AN API PROFICIENCY TEST IN A BACT/ALERT SA AND SN BOTTLE. THE TWO BOTTLES GREW BACILLUS SPECIES, BUT THIS ORGANISM WAS NOT THE PROFICIENCY TEST'S EXPECTED RESULT. THE CHALLENGE CONTAINED AN ANAEROBE. MANUFACTURING DIRECTION REVIEW BACT/ALERT® SA (P/N 259789) LOT 1050022 REVIEW OF THE MANUFACTURING DIRECTIONS (MD) 000573 REVISION 36.A WAS CONDUCTED BY THE INVESTIGATOR AT THE DURHAM, NC FACILITY. THE REVIEW ENCOMPASSED AN EVALUATION OF THE FILLING LOT SA LOT 1050021, LABELING AND PACKAGING (FINISHED PRODUCT SA LOT 1050022) AND PROCESSES AND INSPECTIONS. THE REVIEW INCLUDED A REVIEW OF THE COMPLETE BOTTLE FORM, RACK/STACK INSPECTION FORM, AND PACKAGING DEFECT LOG. ALL INSPECTIONS MET ATTRIBUTE LIMITS. QC MICROBIOLOGY, BIOCHEMISTRY, AND ENVIRONMENTAL MONITORING (EM)/ BIOBURDEN TESTING WERE PERFORMED ON BACT/ALERT SA LOT 1050021 IN ACCORDANCE WITH RELEASE C METHODS. THE RESULTS MET THE SPECIFICATIONS. FINISHED GOODS BACT/ALERT® SA BOTTLE, PART NUMBER (P/N) 259789, LOT NUMBER 1050022 MET ALL RELEASE CRITERIA, WAS REVIEWED BY QUALITY ASSURANCE (QA) AND 2071 CASES WERE RELEASED FOR DISTRIBUTION TO THE FIELD ON 19JAN18. BACT/ALERT® SN (P/N 259790) LOT 1049978 REVIEW OF THE MANUFACTURING DIRECTIONS (MD) 000572 REVISION 34.A WAS CONDUCTED BY THE INVESTIGATOR AT THE DURHAM, NC FACILITY. THE REVIEW ENCOMPASSED AN EVALUATION OF THE FILLING LOT SN LOT 1049977, LABELING AND PACKAGING (FINISHED PRODUCT SN 1049978) AND PROCESSES AND INSPECTIONS. THE REVIEW INCLUDED A REVIEW OF THE COMPLETE BOTTLE FORM, RACK/STACK INSPECTION FORM, AND PACKAGING DEFECT LOG. ALL INSPECTIONS MET ATTRIBUTE LIMITS. QC MICROBIOLOGY, BIOCHEMISTRY, AND ENVIRONMENTAL MONITORING (EM)/ BIOBURDEN TESTING WERE PERFORMED ON BACT/ALERT SN LOT 1049977 IN ACCORDANCE WITH RELEASE C METHODS. THE RESULTS MET THE SPECIFICATIONS. FINISHED GOODS BACT/ALERT® SN BOTTLE, PART NUMBER (P/N) 259790, LOT NUMBER 1049978 MET ALL RELEASE CRITERIA, WAS REVIEWED BY QUALITY ASSURANCE (QA) AND 2466 CASES WERE RELEASED FOR DISTRIBUTION TO THE FIELD ON 09FEB18. ON 23AUG18 THE CUSTOMER CONTACTED BIOMÉRIEUX AND STATED THE PROFICIENCY PROVIDER ((B)(6)) DETERMINED THE SAMPLE WAS CONTAMINATED AND WOULD NOT BE GRADED. THE CUSTOMER DID NOT WANT TO PROVIDE ANY FURTHER INFORMATION AFTER THIS DATE. LEVEL 2 CUSTOMER SERVICE CONTACTED THE PROFICIENCY PROVIDER WHO CONFIRMED THE ISSUE WAS RELATED TO SAMPLE CONTAMINATION ON THEIR END, AND THE EXPECTED ORGANISM SHOULD HAVE BEEN BACTEROIDES FRAGILIS. THE INVESTIGATION CONCLUDED THE ROOT CAUSE OF THIS INCIDENT WAS THAT SURVEY SAMPLE BL-01 WAS CONTAMINATED WITH BACILLUS SPECIES GIVING DISCREPANT RESULTS. THERE WAS NO PRODUCT MALFUNCTION ASSOCIATED WITH THE BACT/ALERT SA CULTURE BOTTLE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH BACT/ALERT® SN CULTURE BOTTLE (REFERENCE (B)(4).). THE CUSTOMER REPORTED DURING AN API STUDY THEY INOCULATED A BACT/ALERT SN AND A BACT/ALERT SA CULTURE BOTTLE. BOTH BOTTLES REPORTED POSITIVE IN THREE (3) DAYS FOR BACILLUS SPECIES. RESULTS FOR THE STUDY WERE REPORTED AS BACILLUS; HOWEVER THE CUSTOMER EXPECTED A DIFFERENT ORGANISM THAT WAS ANAEROBIC. THERE IS NO PATIENT ASSOCIATED WITH THIS EVENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640359 BACT/ALERT® SN CULTURE BOTTLE BACT/ALERT® SN CULTURE BOTTLE MDB BIOMERIEUX INC. 1049978 03573026055813

    Patients

    Seq Age Sex Outcome Treatment
    1