BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FN PLUS

    MDR report key: 8904289 · Received August 17, 2019

    Report

    Report Number
    3002769706-2019-00049
    Event Type
    Malfunction
    Date Received
    August 17, 2019
    Report Date
    March 5, 2020
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357917
    PMA / PMN Number
    K121455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN POLAND NOTIFIED BIOMÉRIEUX OF OBTAINING TWO FALSE NEGATIVE RESULTS FROM A SINGLE PATIENT IN ASSOCIATION WITH THE BACT/ALERT ® FN PLUS BLOOD CULTURE BOTTLE (REFERENCE 410852, LOT 4052871). THE CUSTOMER STATED BOTH BOTTLES WERE INCUBATED FOR FIVE DAYS AND FLAGGED NEGATIVE. THESE BOTTLES WERE THEN SUB-CULTURED AND WERE POSITIVE FOR GROWTH OF PROPIONIBACTERIUM ACNES (P. ACNES). IN RESPONSE TO THE CUSTOMER, COMPLAINT BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION. THE INVESTIGATION EXAMINED THE BACT/ALERT® FN PLUS MANUFACTURING DIRECTIONS, INCLUDING THE QUALITY CONTROL RELEASE TESTING DOCUMENTATION; ALL RESULTS WERE DETERMINED TO BE WITHIN SPECIFICATION. BACT/ALERT® FN PLUS LOT 4052871 MET ALL QUALITY FINISHED GOODS RELEASE CRITERIA AND WAS RELEASED BY QUALITY ASSURANCE ON 20-FEB-2019. THE BACT/ALERT® FN PLUS INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO PROVIDE SUFFICIENT CAUTION FOR THE USER ON THE INTERPRETATION OF A NEGATIVE RESULT. THE ROOT CAUSE WAS NOT DETERMINED. THE BOTTLE PERFORMED AS EXPECTED BASED ON A REVIEW OF THE DATA PROVIDED FROM THE CUSTOMER. POTENTIAL CONTRIBUTING FACTORS OF THE FALSE NEGATIVE RESULT OF THIS FN PLUS BOTTLE INCLUDE: 1. THE ORGANISM, P. ACNES, BEING A FASTIDIOUS, SLOW GROWING MICROORGANISM, MAY REQUIRE A LONGER INCUBATION PERIOD THAN A 5-DAY PROTOCOL. 2. IN THE CLINICAL BLOOD CULTURE SAMPLE, P. ACNES CAN BE A CONTAMINANT FROM THE SKIN DURING THE BLOOD COLLECTION. IN SUCH CASES, THE CONTAMINATION MAY BE LOW-LEVEL CFU/BOTTLE, RESULTING IN A TIME TO DETECTION LONGER THAN THE 5-DAY TEST PERIOD. THE BACT/ALERT ® FN PLUS BLOOD CULTURE BOTTLE (REFERENCE 410852, LOT 4052871) IS FUNCTIONING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING TWO FALSE NEGATIVE RESULTS IN ASSOCIATION WITH THE BACT/ALERT ® FN PLUS BLOOD CULTURE BOTTLES (REFERENCE 410852, LOT 4052871). THE CUSTOMER STATED BOTH BOTTLES WERE INCUBATED FOR FIVE DAYS AND FLAGGED NEGATIVE. THESE BOTTLES WERE THEN SUB-CULTURED AND WERE POSITIVE FOR GROWTH OF PROPIONIBACTERIUM ACNES (P. ACNES). ALTHOUGH THE CUSTOMER DID FOLLOW THE FIVE DAY INCUBATION PROTOCOL, P. ACNES IS A FASTIDIOUS SLOW GROWING MICROORGANISM WHICH MAY REQUIRE A LONGER INCUBATION PERIOD. THE BOTTLE INSTRUCTIONS FOR USE (IFU) NOTES THIS A LIMITATION OF THE TEST IF FASTIDIOUS MICROORGANISMS ARE SUSPECTED. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY 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
    697777 BACT/ALERT® FN PLUS BACT/ALERT® FN PLUS MDB BIOMERIEUX INC. 4052871 03573026357917

    Patients

    Seq Age Sex Outcome Treatment
    1