BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FN PLUS

    MDR report key: 8413284 · Received March 12, 2019

    Report

    Report Number
    3002769706-2019-00006
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    January 30, 2019
    Report Date
    August 7, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357917
    PMA / PMN Number
    K121455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED FOR A CUSTOMER REPORT THAT A BACT/ALERT® FN PLUS BOTTLE CRACKED AND LEAKED IN THE INSTRUMENT. ONE BROKEN AND LEAKING BOTTLE WAS FOUND INSIDE THE BACT/ALERT® 3D INSTRUMENT. CLEAR PICTURES OF THE BROKEN PART OF THE BOTTLE WERE NOT PROVIDED BY THE CUSTOMER AS THE IMPACTED BOTTLE WAS DISCARDED. PICTURES FROM THE BACT/ALERT® 3D INSTRUMENT AND SCREEN SHOTS WERE OBTAINED. THE CUSTOMER INDICATED THERE WAS NO SPECIFIC HARM OR INJURY TO ANY EMPLOYEE OR THE PATIENT DUE TO THIS INCIDENT. THE CUSTOMER INDICATED THE POSITIVE BOTTLE RESULT WAS DELAYED BY TWO DAYS, THUS DELAYING PATIENT TREATMENT. THE REASON FOR THE TWO DAY DELAY WAS NOT CLEAR BASED ON REVIEW OF COMPLAINT TEXT. THE INVESTIGATION EXAMINED THE BACT/ALERT® FN PLUS LOT 4051577 PACKAGING INSPECTIONS, INCLUDING THE QUALITY ACCEPTABLE QUALITY LIMIT INSPECTION DOCUMENTATION, AND ALL THE RESULTS WERE WITHIN SPECIFICATION. QUALITY ASSURANCE SUBSEQUENTLY RELEASED THE LOTS FOR DISTRIBUTION TO THE FIELD ON 24AUG18. 300 RETAIN BOTTLES FROM LOT 4051577 WERE VISUALLY INSPECTED BY THE INVESTIGATOR FOR ANY EVIDENCE OF BROKEN BOTTLES. THERE WERE ZERO BOTTLES FOUND TO BE BROKEN. THE INFORMATION OUTLINED IN THE BACT/ALERT® FN PLUS INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USERS "PRIOR TO USE, THE BACT/ALERT® CULTURE BOTTLES SHOULD BE EXAMINED FOR EVIDENCE OF DAMAGE OR DETERIORATION (DISCOLORATION). BOTTLES EXHIBITING EVIDENCE OF DAMAGE, LEAKAGE, OR DETERIORATION SHOULD BE DISCARDED." A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. IT IS PROBABLE THAT THE BOTTLE WAS DROPPED DURING TRANSPORT TO THE LAB; HOWEVER, THE CUSTOMER DID NOT REPORT THE BOTTLE WAS DROPPED AT ANY POINT SO THE TRUE ROOT CAUSE CANNOT BE CONFIRMED. PLASTIC BACT/ALERT BOTTLES ARE BREAK RESISTANT, BUT IF DROPPED IT IS POSSIBLE FOR THE BOTTLE TO CRACK ON THE BOTTOM. CRACKS MAY NOT LEAK UNTIL THE BOTTLE IS HEATED AFTER BEING LOADED INTO THE INSTRUMENT, AS HEATING CAN CAUSE CRACKS TO EXPAND. GLOBAL CUSTOMER SERVICE ADVISES ALL BOTTLES BE EXAMINED FOR DAMAGE BEFORE LOADING IN THE INSTRUMENT, IN ADDITION TO THE INSPECTION BEFORE USE. TRENDING IDENTIFIED NO OTHER BROKEN BOTTLE COMPLAINTS FOR BACT/ALERT® FN PLUS, LOT 4051577 BESIDES THE COMPLAINT UNDER INVESTIGATION. NO ADVERSE TREND WAS IDENTIFIED UPON CONCLUSION OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THAT A BACT/ALERT® FN PLUS BOTTLE CRACKED AND LEAKED IN THE INSTRUMENT. THE BOTTLE FLAGGED POSITIVE AT 0.98 DAYS, AND WHEN IT WAS UNLOADED ON (B)(6) 2019 FROM THE INSTRUMENT, BLOOD LEAKAGE WAS OBSERVED FROM A CRACK ON THE BOTTLE. BLOOD CAME IN CONTACT WITH THE GLOVED HAND OF THE USER WHO WAS ALSO WEARING A LAB COAT. THE USER FOLLOWED THE DECONTAMINATION PROCESS . THE LOT (4051577) OF BOTTLES WAS CHECKED WITH NO OTHER PROBLEMS OBSERVED. THE CUSTOMER REPORTED THAT THE BACTERIA WAS SUCCESSFULLY ISOLATED FROM THIS POSITIVE BOTTLE AND IDENTIFIED AS STAPHYLOCOCCUS AUREUS. THE PATIENT HAD ANOTHER BOTTLE TESTED AND THE RESULT WAS THE SAME. THERE WAS DELAY OF TWO DAYS FOR REPORTING RESULTS WHICH ALSO DELAYED THE CORRECT ANTIBIOTIC TREATMENT. 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 THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206614 BACT/ALERT® FN PLUS BACT/ALERT® FN PLUS MDB BIOMERIEUX INC. 4051577 03573026357917

    Patients

    Seq Age Sex Outcome Treatment
    1