BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT BPN CULTURE BOTTLE

    MDR report key: 4824031 · Received June 8, 2015

    Report

    Report Number
    3002769706-2015-00041
    Event Type
    Injury
    Date Received
    June 8, 2015
    Date of Event
    May 11, 2015
    Report Date
    June 3, 2015
    Manufacturer
    BOIMÉRIEUX, INC.
    Product Code
    LRG
    PMA / PMN Number
    BK050043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO PROHIBITIVE SHELF-LIFE, THE CUSTOMER DID NOT SUBMIT PLATELET POOL ISOLATES FOR INVESTIGATIONAL TESTING. A BACT/ALERT DATA BACK-UP FILE WAS OBTAINED FROM THE CUSTOMER. THE BOTTLE HISTORIES AND READINGS FOR THE BACT/ALERT BPN BOTTLE WERE EXTRACTED FROM THE DATA BACKUP. THE HISTORIES WERE NORMAL AND SHOWED THE BOTTLE FLAGGED NEGATIVE AFTER 7 DAYS. THE READINGS WERE INTERPOLATED WITH AN ALGORITHM TOOL, AND WERE DETERMINED NEGATIVE. STATISTICAL EVALUATION OF THE BOTTLE READINGS INDICATES THAT BOTH THE FAST AND SLOW SLOPE MEASUREMENTS SHOW AN INITIAL SPIKE BUT THEN DIMINISHED OVER TIME, AND DID NOT ACCUMULATE ENOUGH MOMENTUM FOR A SIGNAL. THE INVESTIGATION EXAMINED THE BACT/ALERT BPN LOT 1040890 MEDIA FORMULATION, FILLING, AND PACKAGING RECORDS, INCLUDING THE QUALITY CONTROL ACCEPTABLE QUALITY LIMIT INSPECTION DOCUMENTATION AND ALL THE RESULTS WERE WITHIN SPECIFICATION. RETAINED SAMPLES FROM BACT/ALERT BPN LOT 1040890 WERE CHALLENGED IN AN INTERNAL STUDY TO CONFIRM RECOVERY OF B. CEREUS ATCC 11778. THE BACT/ALERT BPN LOT 1040890 PERFORMED AS EXPECTED ACCORDING TO SPECIFICATION. THE BACT/ALERT BPN INSTRUCTIONS FOR USE (IFU) WERE REVIEWED. THE PLATELET SPECIMEN COLLECTION AND PREPARATION SECTION STATES "THE LEUKOCYTE REDUCED PLATELET SPECIMEN MUST BE COLLECTED USING STERILE PROCEDURES TO REDUCE THE RISK OF CONTAMINATING THE SAMPLING SITE AND SAMPLING SITE COUPLER. THE PLATELET SPECIMEN SHOULD BE TAKEN AT LEAST 24 HOURS AFTER COLLECTION TO ALLOW FOR NATURAL PROLIFERATION IN THE PLATELET PRODUCT." IN THE PROCEDURAL NOTES AND PRECAUTIONS SECTION OF THE IFU, THE USER IS CAUTIONED TO TAKE GREAT CARE IN ORDER TO PREVENT CONTAMINATION, HIGHLIGHTING THE IMPORTANCE OF PROPER ASEPTIC TECHNIQUE. THE LABORATORY PROCEDURE STATES "NEGATIVE CULTURES MAY BE CHECKED BY SMEAR AND/OR SUB-CULTURE AT SOME POINT PRIOR TO DISCARDING AS NEGATIVE." ADDITIONALLY, IT IS STATED "A REPORT OF "NEGATIVE" SHOULD NOT BE INTERPRETED AS MEANING THAT THE ORIGINAL PRODUCT IS STERILE. THE NEGATIVE STATUS COULD BE DUE TO UNDER-INOCULATION OF THE BOTTLE, NO ORGANISMS PRESENT IN THE INOCULUM, THE NUMBER OF ORGANISMS WERE TOO SMALL FOR DETECTION, OR A CULTURE BOTTLE/MEDIUM THAT DOES NOT SUPPORT THE GROWTH OF THE ORGANISM." THE PROBABLE ROOT CAUSE WAS DETERMINED TO BE INCORRECT CUSTOMER DETERMINATION OF THE BOTTLE RESULTS AS "FALSE" NEGATIVE RATHER THAN "TRUE" NEGATIVE RESULTS. IN ORDER TO DETERMINE THAT A BOTTLE IS TRULY POSITIVE, A SUB-CULTURE MUST BE PERFORMED TO CONFIRM THE PRESENCE OF AN ORGANISM. THIS CONFIRMATION STEP WAS NOT PERFORMED BY THE CUSTOMER. THE INTENDED USE OF THE BACT/ALERT BPN BOTTLES IS FOR QUALITY CONTROL AND NOT FOR THE RELEASE OF THE PLATELET PRODUCT.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    (B)(6) INFORMED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT IN ASSOCIATION WITH THE BACT/ALERT BPN CULTURE BOTTLE (REF. 279018, LOT 1040890, EXP. 09AUG15). A PLATELET POOL SAMPLE WAS INOCULATED TO THE BACT/ALERT BPN CULTURE BOTTLE ON (B)(6) 2015. ON (B)(6) 2015 (THREE DAYS INTO THE 7-DAY BACT/ALERT BPN CULTURE BOTTLE TEST), THE PLATELET POOL ASSOCIATED WITH THE BACT/ALERT BPN CULTURE BOTTLE WAS TRANSFUSED TO A PATIENT. THE PATIENT EXPERIENCED A TRANSFUSIONAL REACTION AS A CONSEQUENCE OF THE TRANSFUSION; THE TRANSFUSION WAS STOPPED. THE PATIENT RECEIVED TREATMENT FOR THE REACTION AND EXPERIENCED NO FURTHER INCIDENT. THOUGH THE HOSPITAL STAFF STATES A BACILLUS SPECIES WAS IDENTIFIED IN THE TRANSFUSION BAG AND IN A BLOOD SPECIMEN COLLECTED FROM THE PATIENT, THE BACT/ALERT BPN CULTURE BOTTLE WAS NEGATIVE AT 7 DAYS. AN INVESTIGATION WILL BE INITIATED BY BIOMÉRIEUX. HOWEVER, A PLATELET POOL SAMPLE IS UNAVAILABLE FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367796 BACT/ALERT BPN CULTURE BOTTLE BACT/ALERT BPN LRG BOIMÉRIEUX, INC. 1040890

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention