BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE

    MDR report key: 8226076 · Received January 8, 2019

    Report

    Report Number
    3002769706-2019-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Report Date
    July 16, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357900
    PMA / PMN Number
    K121461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED FOLLOWING A CUSTOMER REPORT OF POTENTIAL CONTAMINATION ASSOCIATED WITH BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE (REFERENCE 410851). THE CUSTOMER REPORTED TEN (10) INOCULATED BOTTLES GAVE POSITIVE GROWTH (CONTAMINATION) OF STREPTOCOCCUS SPP. TWO (2) UN-INOCULATED BOTTLES WERE INCUBATED AND ONE (1) ALSO GREW THE SAME STREPTOCOCCUS SPP. THE INVESTIGATION EXAMINED THE BACT/ALERT® FA PLUS BOTTLE MANUFACTURING RECORDS FOR LOT 4051065, THE COMPLAINT DATA, AND DIRECTIONS IN THE BOTTLE INSTRUCTIONS FOR USE [IFU]. NO EVIDENCE WAS FOUND IN THE MANUFACTURING RECORD REVIEW TO SHOW A PROBLEM WITH CONTAMINATION OF BOTTLES, OR THE PRESENCE OF STREPTOCOCCI BEFORE RELEASE. THE BATCH MET ALL RELEASE CRITERIA AND QUALITY ASSURANCE SUBSEQUENTLY RELEASED THE LOTS FOR DISTRIBUTION TO THE FIELD ON 04MAY18. TWO HUNDRED [200] RETAINED BOTTLES FOR THIS LOT WERE EXAMINED AND NONE WERE FOUND TO SHOW ANY SIGNS OF CONTAMINATION. A HISTORICAL REVIEW FOR DATE RANGE 10DEC17 TO 07JUN19 OF ALL BACT/ALERT® BOTTLE COMPLAINTS WITH CONTAMINATION ERROR CODES DETERMINED THERE IS NO TREND FOR CONTAMINATION ISSUES, OR FOR STREPTOCOCCUS SPECIES. THE BACT/ALERT® FA PLUS CULTURE BOTTLE LOT 4051065 HAS NO OTHER COMPLAINTS FOR CONTAMINATION AS OF 13JUN19. 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 2018 THAT EXAMINED ALL INOCULATED BOTTLE CONTAMINATION COMPLAINTS FROM 01JAN18 THROUGH 09NOV18 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. A RECENT JOURNAL PUBLICATION DOES INDICATE THAT ALPHA HEMOLYTIC STREPTOCOCCI [STREP VIRIDANS] ARE A COMMON BLOOD CULTURE CONTAMINANT DURING INOCULATION OF BLOOD CULTURES. 1 1S. DARGERE, H. CORMIER, R. VERDON. CONTAMINANTS IN BLOOD CULTURES: IMPORTANCE, IMPLICATIONS, INTERPRETATION AND PREVENTION. CLINICAL MICROBIOLOGY AND INFECTION. 24 [2018] 964-969. 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. 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 IN (B)(6) NOTIFIED BIOMÉRIEUX POTENTIAL CONTAMINATION ASSOCIATED WITH BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE (REFERENCE 410851). THE CUSTOMER REPORTED TEN (10) INOCULATED BOTTLES GAVE POSITIVE GROWTH (CONTAMINATION) OF STREPTOCOCCUS SPP. TWO (2) UN-INOCULATED BOTTLES WERE INCUBATED AND ONE (1) ALSO GREW THE SAME STREPTOCOCCUS SPP. THERE WAS IMPACT TO THE PATIENT, NO CHANGE IN PATIENT'S DRUG TREATMENT PLAN, HOWEVER EXTRA DIAGNOSTIC TESTING WAS ORDERED/PERFORMED. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20170 BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE MDB BIOMERIEUX INC. 4051065 03573026357900

    Patients

    Seq Age Sex Outcome Treatment
    1