BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC FX - TOP UNIT

    MDR report key: 1526916 · Received November 2, 2009

    Report

    Report Number
    1119779-2009-00009
    Event Type
    Malfunction
    Date Received
    November 2, 2009
    Date of Event
    October 7, 2009
    Report Date
    October 29, 2009
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    JTA
    PMA / PMN Number
    K915796A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BACTEC FX IS COMPOSED OF MULTIPLE ROW BOARDS WHICH READ THE BOTTLES TO DETERMINE GROWTH IN THE BLOOD CULTURE VIAL. IN THIS EVENT, THE DEFECTIVE ROW BOARD WAS RETURNED TO BD FOR INVESTIGATION. INVESTIGATION INTO THE ROW BOARD FAILURE WAS INITIALLY ABLE TO DUPLICATE THE LED FAILURE WHICH CAUSED A ZERO READING. COMPONENT LEVEL FAULT HAS NOT BEEN ISOLATED AS THE COMPONENT IS NOW WORKING AND HAS NOT FAILED AGAIN. IN THE SOFTWARE FOR THIS INSTRUMENT, THERE IS AN ALGORITHM THAT APPLIES ONLY TO ANAEROBIC MEDIA. THIS ALGORITHM PREVENTS FALSE NEGATIVES FROM HYDROGEN SULFIDE (HS) PRODUCING ORGANISMS. THIS ALGORITHM DID NOT ALLOW FOR A ZERO READING. WHEN A COMBINATION OF EVENTS OCCUR, THE ZERO READ FAILURE OCCURS INDEPENDENTLY IN A ROW BOARD AND AN ANAEROBIC BOTTLE IS IN THE STATION, IT CAUSED A ZERO READING IN THE STATION. THE HS ALGORITHM, WHICH DOES NOT ACCOUNT FOR ZERO READINGS, CAUSED THE INSTRUMENT TO NOT RECOGNIZE A BOTTLE WAS PRESENT IN THE SYSTEM. IF THE ZERO READ FAILURE OCCURS IN COMBINATION WITH ANOTHER TYPE OF BOARD FAILURE, OR IN THE PRESENCE OF AN AEROBIC CULTURE VIAL, THE ALGORITHM WOULD ALLOW THE INSTRUMENT TO IDENTIFY PRESENCE OF A BOTTLE AND ALARM THE CUSTOMER TO MOVE THE BOTTLE TO ANOTHER STATION. IF THE BOTTLE HAS NOT BEEN READ FOR GREATER THAN 40 MINUTES, THE CUSTOMER IS INSTRUCTED TO SMEAR AND SUBCULTURE THE BOTTLE. BASED ON THE NUMBER OF BOARDS IN THE FIELD AND FAILURES TO DATE, THE ESTIMATE THAT THIS ISSUE WOULD OCCUR A SECOND TIME IS 0.01%. ADDITIONALLY, BASED ON HOW CUSTOMERS USE THE PRODUCT, OF THE DEVICES THAT MAY MALFUNCTION, THE LIKELIHOOD THAT THIS WOULD CAUSE AN INJURY IS 0.00025%. A SOFTWARE REVISION IS BEING DEVELOPED, TESTED AND DUPLICATED TO BE RELEASED TO THE FIELD. BD WILL CONTINUE TO CLOSELY MONITOR THIS SITUATION.

    Description of Event or Problem · 1

    CUSTOMER WAS PLACING BLOOD CULTURE VIALS INTO THE BACTEC FX. WHEN THE INSTRUMENT WENT TO READ THE VIALS, IT DETECTED BAD STATIONS AND ALARMED FOR THE AEROBIC BOTTLE. THE CUSTOMER IMMEDIATELY MOVED THE VIALS TO ANOTHER STATION AND BLOCKED THE BAD STATIONS. TWO DAYS LATER, THE CUSTOMER NOTICED THAT THE ANAEROBIC MATES TO THOSE AEROBIC CULTURE VIALS WERE STILL IN THE ORIGINAL RACK. THE CUSTOMER PULLED THE GROWTH PLOTS AND NOTED THERE WERE NO READINGS FOR THESE VIALS. VIALS WERE REMOVED FROM THE INSTRUMENT, GRAM STAINED AND SUBCULTURED. NO GROWTH WAS OBSERVED ON THE SUBCULTURE AND NO ORGANISM SEEN ON THE GRAM STAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD BACTEC FX - TOP UNIT JTA BD DIAGNOSTIC SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1