BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA¿ READA COMPACT

    MDR report key: 4892653 · Received July 2, 2015

    Report

    Report Number
    3010141591-2015-00001
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 3, 2015
    Report Date
    August 3, 2015
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BD QUALITY HAS INVESTIGATED THIS CUSTOMER'S INCIDENT AS REPORTED AND IT HAS BEEN CONFIRMED. THIS SITE IS USING A CUSTOMER-REQUESTED MODIFIED VERSION OF (B)(4)¿ SOFTWARE. THIS VERSION PERMITS THE CUSTOMER TO HAVE A DESTINATION STEP IN THE FIRST STEP OF THE PROGRAM AND WILL ALLOW FOR TWO (2) DIFFERENT INCUBATION TYPES IN ONE PROGRAM FOR AN ANALYSIS SET. WHEN PLATE INCUBATION IS INTERRUPTED AND THEN REINTRODUCED INTO THE SYSTEM, SOME OF THE CUSTOMER'S PROGRAMS COULD BE AFFECTED AND THESE PLATES WOULD MOVE INTO THE NEXT PROGRAMMED STEP EVEN IF INCUBATION TIME HAD NOT FULLY PASSED. THIS PHENOMENON IS CURRENTLY UNDER INVESTIGATION TO DETERMINE ROOT CAUSE. A CORRECTIVE ACTION/PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED TO ADDRESS THE INCIDENT. AT THIS TIME NO TRENDS HAVE BEEN IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. A HARD COPY OF THIS REPORT WAS MAILED ON (B)(4) 2015. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE BD KIESTRA READA COMPACT IS THE INCUBATION AND IMAGING MODULE DESIGNED FOR USE WITH THE TOTAL LABORATORY AUTOMATION (TLA) AND WORK CELL AUTOMATION (WCA) LINES OF BD KIESTRA PRODUCTS. BD HAS INITIATED AN INVESTIGATION FOR THIS REPORT OF PREMATURE IMAGING BY THE BD KIESTRA READA COMPACT. BASED ON THE INFORMATION CURRENTLY AVAILABLE WE ARE UNABLE TO DETERMINE THE OCCURRENCE OF THE PHENOMENON OR IF IT WOULD LIKELY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. BD WILL FILE A SUPPLEMENTAL REPORT WHEN THE INVESTIGATION IS COMPLETE AND ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    BD QUALITY HAS CONFIRMED THAT THIS IS THE ONLY CUSTOMER SITE WITH THIS VERSION OF BD PROCEEDA¿ SOFTWARE. A BD FIELD REPRESENTATIVE WAS DISPATCHED TO THE CUSTOMER SITE TO CORRECT THE CUSTOMER'S PROGRAMMING STEPS AND PREVENT ANY FURTHER RECURRENCE. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP REPORT TO REPORT 3010141591-2015-00001 WHICH FILED TO THE FDA ON (B)(4) 2015. THIS REPORT CONTAINS ADDITIONAL INFORMATION FOR THE METHOD CODE, RESULTS CODE, CONCLUSIONS CODE AND MANUFACTURER'S NARRATIVE ONLY. A PAPER COPY OF THIS FOLLOW-UP REPORT WAS ALSO MAILED TO THE FDA ON (B)(4) 2015.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PLATES INOCULATED WITH PATIENT SPECIMEN WERE PREMATURELY IMAGED BY THE BD KIESTRA READA COMPACT WHEN THEY PERFORMED MAINTENANCE ON THE INSTRUMENT. THE PLATES WERE AUTOMATICALLY REMOVED FROM THE BD KIESTRA READA COMPACT AND SENT TO THE STACKER AREA PENDING THE NEXT STEP IN ITS PROCESS. WHEN THE TECHNICIAN "ACKNOWLEDGED" COMPLETION OF THE MAINTENANCE, A PORTION OF THE PLATES WERE MOVED TO THE IMAGING STEP INSTEAD OF BEING RETURNED TO INCUBATION. THE CUSTOMER COMMUNICATED THAT THEY RECOGNIZED THE AFFECTED PLATES AT THE TIME THEY WERE IMAGED AND THERE HAS BEEN NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    THIS IS A SECOND FOLLOW-UP FOR REPORT 3010141591-2015-00001 (FDA INITIAL NOTIFICATION 07/02/2015; FDA FOLLOW-UP # 1 ON 8/31/2015). THIS REPORT CONTAINS UPDATED INFORMATION FOR THE MANUFACTURER'S NARRATIVE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433091 BD KIESTRA¿ READA COMPACT BATH, INCUBATORS/WATER, ALL JTQ BD KIESTRA LAB AUTOMATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other