BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT SA

    MDR report key: 6129009 · Received November 28, 2016

    Report

    Report Number
    3002769706-2016-00489
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Report Date
    February 16, 2017
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    MDB
    PMA / PMN Number
    K020931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION: THE INVESTIGATION EXAMINED THE BACT/ALERT MANUFACTURING DIRECTIONS, INCLUDING THE QUALITY CONTROL RELEASE TESTING DOCUMENTATION, AND ALL RESULTS WERE WITHIN SPECIFICATION. QUALITY ASSURANCE SUBSEQUENTLY RELEASED THE LOTS FOR DISTRIBUTION TO THE FIELD. THE CUSTOMER LIS IS THE ROOT CAUSE OF THIS INVESTIGATION. SINCE ALL BOTTLE IDS ARE RETAINED IN MEMORY INDEFINITELY AND BOTTLE ID NUMBERS ARE FINITE, A DUPLICATION OF BOTTLE ID WILL EVENTUALLY OCCUR. THE CURRENT WORKFLOW OF USING A GENERIC BOTTLE BARCODE LABEL ON BOTTLES RECOGNIZED AS DUPLICATE SHOULD BE CONTINUED. BIOMÉRIEUX RECOMMENDS A PURGE OF BOTTLE IDS FROM THE LIS DATABASE WITH MORE THAN A PREDETERMINED NUMBER OF DAYS OF BEING UNLOADED BASED ON CUSTOMER NEEDS. AS INTERIM MITIGATION, (B)(4) CASES OF BACT/ALERT SA PRODUCT WERE SHIPPED. THESE BOTTLE IDS WERE EVALUATED AGAINST THE CUSTOMER LIS TO ENSURE NO PREVIOUSLY PROVIDED BOTTLE IDS WERE REPEATED. THE COMPLAINT WAS RECEIVED FROM ONE CUSTOMER AT TWO DIFFERENT LOCATIONS FOR ALLEGED DUPLICATE BOTTLE IDS. THE ROOT CAUSE WAS DETERMINED TO BE LIMITATION CREATED BY THE CUSTOMER LIS SETUP. THE BOTTLES PERFORMED AS INTENDED, NO IRREGULARITIES WERE IDENTIFIED DURING THE PRODUCTION PROCESS AND THE LOT ITSELF WAS NOT ADVERSELY IMPACTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A PROBLEM WITH DUPLICATE BAR CODES ASSOCIATED WITH BACT/ALERT® SA BOTTLES. THE CUSTOMER REPORTED THAT IN THE EMERGENCY ROOM OF THE FACILITY, THEY IDENTIFIED DUPLICATE BAR CODES FOR THE BACT/ALERT® SA BOTTLES AND THAT THEIR ERP SYSTEM WOULD NOT ALLOW THE USER TO ENTER A GENERIC BARCODE. AS A RESULT, THEY WERE UNABLE TO ENTER THE BLOOD CULTURE SAMPLES OR CREATE RECORDS IN THE LABORATORY INFORMATION SYSTEM (LIS). THE CUSTOMER REPORTED HAVING TO SEND SAMPLES TO ANOTHER FACILITY WHERE A WORKAROUND IN THE ERP SYSTEM IS BEING PERFORMED; HOWEVER, THIS HAS THE POTENTIAL TO CAUSE RESULT DELAYS. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED RELATED TO THIS ISSUE. THE BACT/ALERT® BOTTLE LABEL SUPPLIER (CCL) WAS NOTIFIED THAT BIOMÉRIEUX HAD RECEIVED A COMPLAINT FOR A DUPLICATE BOTTLE ID NUMBER. CCL INDICATED THE NUMBERS WERE GENERATED BY A BIOMERIEUX-SUPPLIED SOFTWARE. THE NUMBERS ARE 100% SCANNED BY CCL FOR NO READ, NO SCAN, POOR QUALITY, AND TO ENSURE THERE ARE NO DUPLICATED BOTTLE ID NUMBERS WITHIN THE SET. AS PART OF THE CCL INVESTIGATION, THE NUMBERS REPORTED AS DUPLICATE WERE COMPARED TO A DATABASE OF BOTTLE ID NUMBERS CCL HAD GENERATED PRIOR TO BIOMÉRIEUX SUPPLYING THE BOTTLE ID NUMBERS. THE REPORTED BOTTLE ID NUMBERS WERE CONFIRMED TO HAVE BEEN PREVIOUSLY ISSUED. CCL CONCLUDED THE ROOT CAUSE WAS THAT BIOMÉRIEUX HAD SUPPLIED BOTTLE ID NUMBERS IDENTICAL TO NUMBERS CCL HAD HISTORICALLY GENERATED. A "RETAIN LABEL ANALYSIS" BY BIOMÉRIEUX CONFIRMED CCL'S CONCLUSION ON SEPTEMBER 12, 2016. FURTHER ANALYSIS OF EQUIPMENT CONFIGURATIONS CONCLUDED "BACT/ALERT® CONNECTED TO OBSERVA®" OR "BACT/ALERT® CONNECTED TO BACT/VIEW" COULD ALLOW THE RESULT FOR A PREVIOUS PATIENT TO BE ASSIGNED TO A NEW PATIENT. HOWEVER, INVESTIGATION DETERMINED IT IS NOT LIKELY THAT BACT/ALERT® CONNECTED TO OBSERVA® WILL IMPACT RESULTS SINCE THE WORKFLOW DELAYS LINKING THE CULTURE BOTTLE TO THE PATIENT RECORD. IN EACH CASE, THE CORRECT RESULT WILL BE ASSIGNED TO THE NEW PATIENT RECORD UPON COMPLETION OF THE BOTTLE TEST. IN ADDITION, CLINICAL ENVIRONMENT MITIGATIONS DECREASE THE LIKELIHOOD OF AN ERRONEOUS RESULT GOING UNNOTICED. CLSI GUIDANCE M47-A, PRINCIPLES AND PROCEDURES FOR BLOOD CULTURES, REGARDING THE REQUIRED NUMBER OF BLOOD CULTURE BOTTLES INDICATES "A SINGLE CULTURE BOTTLE IS CLEARLY INADEQUATE ..... MULTIPLE SETS WOULD HELP A CLINICIAN TO DISTINGUISH .... ." AS THIS GUIDANCE IS EXPECTED TO BE FOLLOWED BY LABORATORIES, OTHER BOTTLES WITHIN THE SET MAY BE POSITIVE AS WELL AND IT IS UNLIKELY THAT A DOCTOR WOULD STOP EMPIRICAL THERAPY BECAUSE OF ONE NEGATIVE BLOOD CULTURE BOTTLE RESULT REPORTED FROM THE LIS. THE EXPECTED PRELIMINARY RESULT WOULD MOST LIKELY BE NEGATIVE-TO-DATE RATHER THAN THE NEGATIVE THAT IS POTENTIALLY REPORTED DUE TO THIS ISSUE. CUMITECH ALSO STATES "IT CAN BE CONCLUDED FROM AVAILABLE DATA THAT TWO TO FOUR BLOOD CULTURES ARE NECESSARY TO OPTIMIZE DETECTION OF BACTEREMIA AND FUNGEMIA." CUMITECH 1C, BLOOD CULTURE IV, STATES THAT PRIOR TO LEAVING THE PATIENT'S BEDSIDE THE FOLLOWING DETAILS ARE TO BE INCLUDED ON CULTURE BOTTLE LABEL(S): TWO UNIQUE IDENTIFIERS (E.G. NAME, BIRTHDATE, SOCIAL SECURITY NUMBER, ETC.); COLLECTOR'S NAME, EMPLOYEE NUMBER, AND/OR EMPLOYEE CODE; COLLECTION SITE (E.G. VEIN, ARM, LEG, ETC.); THE AMOUNT OF BLOOD COLLECTED, IF DIFFERENT FROM THE CULTURE BOTTLE REQUIREMENTS). IF THE BOTTLE IS CALLED POSITIVE, THE TECHNOLOGIST WILL UNLOAD IT TO SUBCULTURE AND GRAM STAIN. PROPER BOTTLE LABELING BY THE USER MAKES IT LIKELY THAT THE NEGATIVE RESULT INITIALLY REPORTED WOULD BE DETECTED. ADDITIONALLY, IF THE BOTTLE IS TRUE POSITIVE THE PHYSICIAN IS IMMEDIATELY NOTIFIED AND THE RESULT IS UPDATED IN THE DATABASE MANAGEMENT SYSTEM (I.E. OBSERVA®) OR LABORATORY INFORMATION SYSTEM (LIS). THEREFORE, IT IS HIGHLY LIKELY THAT THE FALSE INITIAL REPORT WOULD BE DETECTED AND THE POSITIVE RESULT WILL BE REPORTED FOR THE CORRECT PATIENT. HEALTH HAZARD ASSESSMENT (HHA) BY MEDICAL DOCTOR INDICATED THE ISSUE IS NOT EXPECTED TO HAVE A NEGATIVE IMPACT ON PATIENT HEALTH DUE TO BOTH PRODUCT MITIGATIONS, AS WELL AS MITIGATIONS THAT OCCUR IN THE CONTEXT OF THE CLINICAL ENVIRONMENT. EVEN THOUGH THERE IS NO NECESSARY CORRECTIVE ACTION NEEDED IN THE FIELD, THIS EVENT IS BEING REPORTED UNDER 21 CFR 803, MEDICAL DEVICE REPORTING AS A REPORTABLE MALFUNCTION. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION HAS BEEN INITIATED TO ENSURE THIS TYPE OF LABELING ISSUE DOES NOT RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780472 BACT/ALERT SA BACT/ALERT SA CULTURE BOTTLE MDB BIOMERIEUX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1