BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    BD KIESTRA¿ UCA POWERED BY BD SYNAPSYS¿ INFORMATICS SOLUTION

    MDR report key: 22864708 · Received August 21, 2025

    Report

    Report Number
    3010141591-2025-00004
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 25, 2025
    Report Date
    November 14, 2025
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JQP
    UDI-DI
    00382904449025
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION OF A COMPLAINT INVOLVING THE BD SYNAPSYS UCA AUTO RELEASE. ACCORDING TO THE INFORMATION PROVIDED, THE CUSTOMER REPORTED THAT THE URINE CULTURE ANALYZER GENERATED AN INCORRECT RESULT BY LABELING A URINE SAMPLE WITH NO BACTERIAL GROWTH AS ¿HEAVY MIXED GROWTH.¿ DURING THE INVESTIGATION, THE TECHNICAL CUSTOMER SERVICE ENGINEER ACCESSED THE APPLICATION SERVER REMOTELY, RESTARTED THE BDK PLATE ANALYZER SERVICE, AND INSTRUCTED THE CUSTOMER TO RESTART THE UCA APPLICATION. THESE ACTIONS RESOLVED THE INCORRECT RESULT REPORTING ISSUE. FOLLOWING THIS ACTION, NO FURTHER ISSUES WERE ENCOUNTERED. BASED ON THE INVESTIGATION, THIS CASE HAS BEEN ASSESSED AS CONFIRMED FOR A BD QUALITY ISSUE. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT. THE ISSUE IN THIS COMPLAINT DOES NOT REQUIRE THE INITIATION OF A CORRECTIVE AND PREVENTATIVE ACTION (CAPA). A DESIGN HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED FOR THIS COMPLAINT. THE COMPLAINT WAS EVALUATED VIA OTHER ELEMENTS OF THE INVESTIGATION. THE RESULTS OF THIS EVALUATION HAVE NOT IDENTIFIED ANY NEW HAZARDS, NEW RISKS, OR SPECIFIC TRENDS. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR TRENDS ASSOCIATED WITH THIS ISSUE.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD KIESTRA¿ UCA POWERED BY BD SYNAPSYS¿ INFORMATICS SOLUTION, A NO GROWTH PLATE REPORTED A RESULT OF "HEAVY MIXED GROWTH" BY THE SYSTEM. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD KIESTRA¿ UCA POWERED BY BD SYNAPSYS¿ INFORMATICS SOLUTION, A NO GROWTH PLATE REPORTED A RESULT OF "HEAVY MIXED GROWTH" BY THE SYSTEM. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418875 BD KIESTRA¿ UCA POWERED BY BD SYNAPSYS¿ INFORMATICS SOLUTION CALCULATOR/DATA PROCESSING MODULE JQP BD KIESTRA LAB AUTOMATION 00382904449025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown