BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® SN CULTURE BOTTLE

    MDR report key: 5070653 · Received September 11, 2015

    Report

    Report Number
    3002769706-2015-00085
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Report Date
    September 1, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    MDB
    PMA / PMN Number
    K021123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT FOR A FALSE NEGATIVE RESULT. THE CUSTOMER COMPLAINT WAS RECEIVED FOR A BACT/ALERT® SN BOTTLE FLAGGING NEGATIVE FOR A KNOWN POSITIVE CAP SURVEY PROFICIENCY SAMPLE CONTAINING FUSOBACTERIUM NECROPHORUM, ON LOT NUMBER 3043442. A REVIEW OF THE DATA LOGS WAS PERFORMED. THE ANALYSIS REVEALED THAT THE CURVES OF THE TWO BOTTLES DO NOT SHOW ANY OBVIOUS SIGNS OF ORGANISM GROWTH. A BATCH RECORD REVIEW FOR LOT 3043442 WAS PERFORMED. THERE WERE NO UNUSUAL INCIDENTS OR NON-CONFORMANCES ASSOCIATED WITH THE PRODUCTION OF THIS LOT. THERE WERE NO OOS RESULTS FOR BACT/ALERT® SN PART NUMBER (P/N 259790), LOT NUMBER 3043442. THE BACT/ALERT® SN BOTTLE WAS NOT SUBCULTURED. IT IS UNCLEAR IF OXYGEN WAS INTRODUCED INTO THE BOTTLE DURING SAMPLE PREPARATION OR INOCULATION, OR IF THE ORGANISM WAS INOCULATED INTO THE SN BOTTLE FIRST AS INSTRUCTED IN THE IFU. THE CAP SURVEY SAMPLE WAS A LYOPHILIZED SAMPLE AND THERE WAS NO INDICATION THAT THE CUSTOMER SUPPLEMENTED THE SAMPLE WITH BLOOD. FASTIDIOUS ORGANISMS REQUIRE BLOOD FOR GROWTH. FUSOBACTERIUM NECROPHORUM IS AN ANAEROBIC FASTIDIOUS ORGANISM, IS VERY SENSITIVE TO OXYGEN, AND IT MAY REACT NEGATIVELY OR EVEN DIE IF OXYGEN IS PRESENT. ADDITIONALLY, THE CUSTOMER DID NOT SUBCULTURE THE BOTTLE IN ORDER TO CONFIRM THE PRESENCE, OR ABSENCE, OF AN ORGANISM. A TREND REVIEW FOR SIMILAR COMPLAINTS WAS PERFORMED FROM 01-SEP-2015 TO 06-OCT-2015. THERE WERE NO COMPLAINTS DETERMINED TO BE RELATED. IT HAS BEEN DETERMINED THAT THERE IS NOT AN ADVERSE TREND FOR THIS ISSUE. THE EXACT ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. A PROBABLE ROOT CAUSE IS UNKNOWN, THERE IS INSUFFICIENT INFORMATION TO DETERMINE A POTENTIAL CAUSE. CONTRIBUTORY FACTORS COULD BE IMPROPER SAMPLE PREPARATION, INSUFFICIENT NUTRIENT CONTENT, INSUFFICIENT ORGANISM VIABILITY, OXYGENATION AND LACK OF BLOOD TO THE SAMPLE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER CONTACTED BIOMERIEUX TO REPORT A DISCREPANT RESULT ASSOCIATED WITH A CAP PROFICIENCY SAMPLE WITH THE BACT/ALERT® SN CULTURE BOTTLE. THE CULTURE BOTTLE HAD A FINAL DETERMINATION OF NEGATIVE; HOWEVER UPON SUBCULTURE, THE RESULT WAS POSITIVE FOR FUSOBACTERIUM NECROPHORUM. AN INTERNAL INVESTIGATION HAS BEEN INITIATED BY BIOMERIEUX TO DETERMINE THE CAUSE OF THIS DISCREPANT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602972 BACT/ALERT® SN CULTURE BOTTLE BACT/ALERT® SN CULTURE BOTTLE MDB BIOMERIEUX, INC 3043442

    Patients

    Seq Age Sex Outcome Treatment
    1