BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT ® BPN

    MDR report key: 8444841 · Received March 22, 2019

    Report

    Report Number
    3002769706-2019-00007
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MZC
    UDI-DI
    03573026126735
    PMA / PMN Number
    BK050043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS INITIATED FOLLOWING A CUSTOMER REPORT OF TWO FALSE POSITIVE RESULTS WHILE USING BACT/ALERT ® BPN BOTTLES (REFERENCE# 279019 LOT# 1051492). THE INVESTIGATION EXAMINED THE BACT/ALERT® BPN BOTTLE MANUFACTURING RECORDS FOR LOT 1051492, THE COMPLAINT DATA, AND DIRECTIONS IN THE BOTTLE INSTRUCTIONS FOR USE [IFU]. THE LOT MET ALL RELEASE SPECIFICATIONS AND QUALITY ASSURANCE RELEASED THE LOT FOR DISTRIBUTION TO THE FIELD ON 09AUG18. HISTORICAL REVIEW OF COMPLAINT DATA DETERMINED NO ADVERSE TREND IS PRESENT FOR FALSE POSITIVE COMPLAINTS IN THE BACT/ALERT BPN BOTTLE TYPE OR IN LOT 1051492. THE LOT EXPIRED ON 26JUN19. A REVIEW OF THE BOTTLE IFU AND BACT/ALERT® 3D USER MANUAL FOUND SUFFICIENT GUIDANCE REGARDING TESTING OF BOTTLES. THE SPECIFIC BOTTLE DATA WAS NOT FOUND IN THE BACKUPS PROVIDED BY THE CUSTOMER FOR ANALYSIS. THE ROOT CAUSE FOR THE FALSE POSITIVE RESULTS ARE UNDETERMINED, BUT MOST LIKELY RELATE TO THE USER'S LOADING PATTERN. THE INVESTIGATOR CAN ONLY COMMENT ON THE BOTTLE GRAPHS PROVIDED BY THE CUSTOMER FOR THE COMPLAINT. TWO OF THESE GRAPHS SHOW A DIP IN THE READINGS PRIOR TO THE POSITIVE FLAG THAT COULD BE CONSISTENT WITH A TEMPERATURE CHANGE RELATED TO LOADING PATTERN. LOADING NEW ROOM TEMPERATURE BOTTLES IN THE SAME LOCATIONS WHERE THESE BOTTLES WERE UNDER TEST CAN CAUSE A HEAT TRANSFER IN THE RACK OR DRAWER THAT LEADS TO A DIP IN READINGS. AS THE TEMPERATURE RECOVERS, THE READINGS RISE AGAIN AND CAN FALSELY TRIGGER THE ACCELERATION ALGORITHM ON THE INSTRUMENT. THE CUSTOMER'S LOADING PATTERN WAS ANALYZED IN THE BACT/ALERT 3D BACKUP PROVIDED. THEIR LOADING PATTERN IS TO LOAD ABOUT 10 TO 20 BOTTLES AT THE SAME TIME, MOSTLY TWO TO THREE BOTTLES PER RACK, BUT SOMETIMES MORE. THE BACKUP CONTAINED INSTRUMENT FAULTS FROM 06MAR19 TO 03MAY19, THERE ARE FIVE ERROR 20 [DRAWER OPEN LONGER THAN TWO MINUTES] AND ONE ERROR 81 [BOTTLE LOADED IN A CELL THAT IS WAITING FOR QC]. THE BACKUP SHOWS ACTIVITY IN TWO INCUBATION MODULES. GLOBAL CUSTOMER SERVICE [GCS] RECOMMENDS TO LOAD IN SMALLER BATCHES, ONE BOTTLE PER RACK IN DRAWERS THAT ALREADY HAVE BOTTLES UNDER TEST, TO MINIMIZE THE HEAT LOSS IMPACT. GCS ALSO RECOMMENDS TO AVOID CAUSING ERROR 20 ON THE BACT/ALERT 3D.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF TWO FALSE POSITIVE RESULTS WHILE USING BACT/ALERT ® BPN BOTTLES (REFERENCE# 279019 LOT# 1051492). THESE BOTTLES FLAGGED POSITIVE AND WERE SUB-CULTURED. THEY DID NOT EXHIBIT GROWTH, WHICH INDICATED FALSE POSITIVE RESULTS. THE CUSTOMER CONFIRMED THAT THEY ARE FOLLOWING THE INSTRUCTIONS FOR USE AND DID NOT NOTE ANY ANOMALIES WITH SAMPLE PREPARATION OR THE BOTTLES. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236861 BACT/ALERT ® BPN BACT/ALERT ® BPN MZC BIOMERIEUX INC. 1051492 03573026126735

    Patients

    Seq Age Sex Outcome Treatment
    1