BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT BPN US

    MDR report key: 13110924 · Received December 29, 2021

    Report

    Report Number
    3002769706-2021-00064
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Report Date
    September 27, 2022
    Manufacturer
    BIOMÉRIEUX, INC
    Product Code
    MZC
    UDI-DI
    03573026611323
    PMA / PMN Number
    BK050043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO ONE CUSTOMER COMPLAINT RELATING TO AN INCREASE IN INSTRUMENT FALSE POSITIVE PLATELET CULTURE BOTTLES ON THEIR BACT/ALERT® 3D VERSION B.50 INSTRUMENT SERIAL NUMBERS (B)(6). ---INVESTIGATION--- COMPLAINT TREND ANALYSIS: GLOBAL CUSTOMER SERVICE (GCS) PERFORMED A COMPLAINT TREND ANALYSIS AND DID NOT IDENTIFY THIS ISSUE AS A TREND FOR BACT/ALERT. CUSTOMER DATA REVIEW: THE CUSTOMER DID NOT PROVIDE SUFFICIENT INFORMATION TO EVALUATE THE COMPLAINT, DESPITE REPEATED REQUESTS. NO BOTTLE GRAPHS OR INSTRUMENT BACKUP WERE PROVIDED. IDENTIFY AND VERIFY ROOT CAUSES: NINE WHY¿S ARE DISCUSSED, SEVEN ARE UNKNOWN DUE TO INSUFFICIENT INFORMATION PROVIDED, TWO ARE NOT LIKELY, AND ONE IS POSSIBLE. POSSIBLE ROOT CAUSE -LIKELIHOOD BOTTLE OR SENSOR DEFECT -NOT LIKELY. BOTTLE TRULY CONTAINS AN ORGANISM AND THE POSITIVE RESULT IS NOT FALSE. -NOT LIKELY. HIGH NUMBERS OF WHITE BLOOD CELLS -POSSIBLE. USER HANDLING UNKNOWN. LARGE NUMBERS OF BOTTLE LOADS/UNLOADS -UNKNOWN. HIGH INITIAL VALUE REFLECTANCE READINGS -UNKNOWN. OVERFILLED WITH SAMPLE -UNKNOWN. ENVIRONMENTAL TEMPERATURE -UNKNOWN. BOTTLES NOT FULLY LOADED IN CELL -UNKNOWN. CELL NOISE -UNKNOWN. THE INVESTIGATOR DID NOT HAVE SUFFICIENT INFORMATION TO DETERMINE WHY ONE DONOR LED TO TWO INSTRUMENT FALSE POSITIVE PLATELET BOTTLES ON TWO DIFFERENT DONATION DATES. THE NUMBER AND TYPE OF CELLS IN THE SAMPLE AS WELL AS THE SAMPLE VOLUME COULD CONTRIBUTE TO INCREASED CELLULAR ACTIVITY THAT CHANGES THE BOTTLE¿S SENSOR COLOR. THE INVESTIGATOR IS NOT AWARE OF ANY OTHER CONTRIBUTORS OTHER THAN MICROBIAL GROWTH IN THE PLATELET SAMPLE THAT COULD LEAD TO AN INSTRUMENT FALSE POSITIVE RESULT. A REVIEW OF THE MANUFACTURING BATCH RECORDS FOR THE THREE LOT NUMBERS DID NOT REVEAL ANY ISSUES THAT WOULD CONTRIBUTE TO INSTRUMENT FALSE POSITIVE BOTTLES. ALL THREE BACT/ALERT LOTS MET THEIR RELEASE SPECIFICATIONS. QUERIES OF THE MANUFACTURING DATA, AND THE COMPLAINT DATA DO NOT REVEAL ANY ADVERSE TREND FOR THE FALSE POSITIVE ERROR CODE OR THE THREE BOTTLE LOT NUMBERS. REVIEW OF INSTRUCTIONS FOR USE: THE LABORATORY PROCEDURE STATES THAT ALL POSITIVE BOTTLES SHOULD BE SMEARED AND SUBCULTURED. IF THE SMEAR IS NEGATIVE, INDICATING A POSSIBLE FALSE POSITIVE, THE BOTTLE SHOULD BE RELOADED INTO THE INSTRUMENT UNTIL GROWTH OF SUBCULTURE OR REDESIGNATION AS POSITIVE. CULTURES WHICH WERE INITIALLY DETERMINED FALSE POSITIVE AND WERE REDESIGNATED POSITIVE SHOULD BE SMEARED AND SUBCULTURED. THE LIMITATIONS OF THE TEST STATES: MANY VARIABLES INVOLVED IN PLATELET CULTURE TESTING CANNOT BE PRACTICALLY CONTROLLED TO PROVIDE TOTAL CONFIDENCE THAT RESULTS OBTAINED ARE DUE SOLELY TO PROPER OR IMPROPER PERFORMANCE OF ANY CULTURE MEDIUM OR DETECTION SYSTEM. 1. A GRAM-STAINED SMEAR FROM A NEGATIVE BOTTLE MAY SOMETIMES CONTAIN A SMALL NUMBER OF NON-VIABLE ORGANISMS THAT WERE DERIVED FROM CULTURE MEDIUM COMPONENTS, STAINING REAGENTS, IMMERSION OIL, OR GLASS SLIDES, THEREFORE, FALSE-POSITIVE RESULTS ARE INDICATED. 2. FALSE POSITIVE READINGS CAN OCCUR DUE TO NOISE ON THE POWERLINE, PLACING THE INSTRUMENT IN DIRECT SUNLIGHT, OR WITH DRAMATIC TEMPERATURE FLUCTUATIONS. 3. FAILURE TO ACHIEVE ADEQUATE LEUKOCYTE REDUCTION MAY RESULT IN FALSE POSITIVE READINGS. THE INVESTIGATOR CONCLUDES THAT THE IFU PROVIDE ADEQUATE DIRECTIONS FOR THE USER. ---CONCLUSION--- A SINGLE ROOT CAUSE WAS NOT IDENTIFIED. THE CUSTOMER DID NOT PROVIDE SUFFICIENT INFORMATION TO EVALUATE THE COMPLAINT, DESPITE REPEATED REQUESTS. NO BOTTLE GRAPHS OR INSTRUMENT BACKUP WERE PROVIDED. GLOBAL CUSTOMER SERVICE (GCS) PERFORMED A COMPLAINT TREND ANALYSIS AND DID NOT IDENTIFY THIS ISSUE AS A TREND FOR BACT/ALERT.

    Description of Event or Problem · 0

    A CUSTOMER IN THE USA NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE RESULT FOR A PLATELET SAMPLE IN ASSOCIATION WITH BACT/ALERT® BPN US (REF 423279, BATCH NUMBER NOT REPORTED, EXPIRATION DATE UNKNOWN). THE CUSTOMER DREW THREE PLATELET SAMPLES WHICH WERE FLAGGED POSITIVE ON THE FIRST AND THIRD RUN. SUB-CULTURE OF THE SAMPLES INDICATED NO GROWTH. THESE TWO FALSE POSITIVE SAMPLES WERE FROM THE SAME DONOR. IT WAS REPORTED THERE WAS NO PATIENT IMPACT; THE APHERESIS PLATELET PRODUCTS WERE RECALLED AND DESTROYED. IT WAS REQUESTED IF THE PHYSICIAN PRESCRIBED ANY ANTIBIOTICS TO THE PATIENT. THE REPLY WAS THAT THE PATIENT WAS NOT TRANSFUSED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007668 BACT/ALERT BPN US BACT/ALERT BPN US MZC BIOMÉRIEUX, INC UNKNOWN 03573026611323

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown