BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACT/ALERT® BPN CULTURE BOTTLE

    MDR report key: 5520951 · Received March 23, 2016

    Report

    Report Number
    3002769706-2016-00058
    Event Type
    Injury
    Date Received
    March 23, 2016
    Date of Event
    November 28, 2015
    Report Date
    March 21, 2016
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    MZC
    PMA / PMN Number
    BK050043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO A (B)(46 EVENT WHILE USING THE BACT/ALERT® BPN CULTURE BOTTLE WAS PERFORMED. THE INVESTIGATION EXAMINED THE MANUFACTURING AND QUALITY CONTROL RECORDS. NO ABNORMALITIES OR ANOMALIES WERE FOUND. INTERVIEW WITH THE CUSTOMER DETERMINED THAT NO SUBCULTURE OR GRAM STAIN WAS PERFORMED ON THE BOTTLES AFTER THEY WERE DETERMINED (B)(6). THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE INCORRECT DETERMINATION OF THE BOTTLE RESULTS AS (B)(6) RATHER THAN (B)(6) RESULTS, I.E. THE BOTTLE DID NOT CONTAIN ANY ORGANISM. A REVIEW OF THE PACKAGE INSERT WAS PERFORMED. UNDER THE PLATELET SPECIMEN COLLECTION AND PREPARATION 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 IFUS, THE USER IS CAUTIONED TO TAKE GREAT CARE IN ORDER TO PREVENT CONTAMINATION, HIGHLIGHTING THE IMPORTANCE OF PROPER ASEPTIC TECHNIQUE. LIKELY CAUSES OF CONTAMINATION ARE LISTED AS: "INADEQUATE ASEPTIC/STERILE TECHNIQUE OR OPERATOR ERROR (E.G., OPERATOR LAB COAT, AEROSOL), SAMPLING OR INOCULATION IN AN INADEQUATE ENVIRONMENT, OR A SPORE PRESENT ON TOP OF THE BACT/ALERT® BOTTLE SEPTUM WHEN INTRODUCING THE SPECIMEN WHICH WAS NOT REMOVED WITH THE 70% ALCOHOL WIPE." THE LABORATORY PROCEDURE STATES "NEGATIVE CULTURES MAY BE CHECKED BY SMEAR AND/OR SUBCULTURE AT SOME POINT PRIOR TO DISCARDING AS NEGATIVE." ADDITIONALLY, A NOTE IS INCLUDED WHICH STATES "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." BASED ON THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AND THE PRODUCT IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER NOTIFIED BIOMERIEUX THAT A (B)(6) PATIENT HAD A TRANSFUSION REACTION WHEN GOING THROUGH A PLATELET TRANSFUSION (FEVER, TACHYCARDIA AND VOMITING) ON (B)(6) 2015. THE POOLED PLATELET CONCENTRATE WAS ORIGINALLY TESTED USING THE BACT/ALERTPA REAGENT. THE TEST RESULT OF THE BACT/ALERT REAGENT WAS A NEGATIVE RESULT AFTER 7 DAYS OF INCUBATION. AFTER THE PATIENT EXPERIENCED THE TRANSFUSION REACTION, THE PLATELET BAG AS WELL AS PATIENT BLOOD WAS TESTED. TESTING FROM BOTH SOURCES WERE POSITIVE FOR ENTEROCOCCUS FAECALIS. THE PATIENT HAS SINCE RECOVERED AFTER TREATMENT WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174843 BACT/ALERT® BPN CULTURE BOTTLE BACT/ALERT® BPN MZC BIOMERIEUX, INC. 3043390

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention