BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIESTRA

    MDR report key: 23193863 · Received October 1, 2025

    Report

    Report Number
    3010141591-2025-00007
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 10, 2025
    Report Date
    December 12, 2025
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION OF A COMPLAINT INVOLVING INSTRUMENT BD KIESTRA INOQULA TRACK. ACCORDING TO THE INFORMATION PROVIDED, THERE WAS SPECIMEN CONTAMINATION, AND NO OTHER ISSUES WERE REPORTED. DURING THE INVESTIGATION, THE FIELD SERVICE ENGINEER (FSE) IDENTIFIED SUSPECTED SPECIMEN CONTAMINATION DURING THE INOCULATION PROCESS. WHOLE GENOME SEQUENCING (WGS) AT CNR CONFIRMED CONTAMINATION OCCURRED BETWEEN THE RECORDING AND INOCULATION STEPS. DIAGNOSTIC ANALYSIS USING KIESTRA/SYNAPSYS TOOLS EXCLUDED CONTAMINATION FROM INOQULA TALON OR READA SYSTEMS, AND AEROSOL GERM CONTAMINATION WAS RULED OUT. ALL QUALITY CONTROLS (QCS) WERE NEGATIVE, AND SUCH CASES REMAIN RARE DUE TO CORRECTIVE ACTIONS ALREADY IMPLEMENTED. THE CUSTOMER WAS CONTACTED TO FINALIZE THE PRODUCT INVESTIGATION REPORT (PIR). IT WAS CONFIRMED THAT THE CONTAMINATION WAS NOT RELATED TO KIESTRA SYSTEMS, AND SYSTEM ROBUSTNESS WAS VALIDATED BY THE CLIENT¿S CONFIRMATION EMAIL. THE PIR PROCESS WAS CLOSED AFTER EXCLUDING SYSTEM-RELATED ISSUES. RECOMMENDATIONS INCLUDE CONTINUING CONFIRMATORY TESTING AND MAINTAINING ENHANCED QC MEASURES. FOLLOWING THIS ACTION, NO FURTHER ISSUES WERE ENCOUNTERED. BASED ON THE INVESTIGATION, THIS CASE HAS BEEN ASSESSED AS CONFIRMED AS A BD QUALITY ISSUE. REVIEW FOUND NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT. THE ISSUE IN THIS COMPLAINT DOES NOT REQUIRE THE INITIATION OF 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. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR TRENDS ASSOCIATED WITH THIS ISSUE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA TRACK HAS BEEN FOUND PRODUCING ERRONEOUS RESULTS. NO PATIENT IMPACT WAS REPORTED. REPORT 3 OF 5.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA TRACK HAS BEEN FOUND PRODUCING ERRONEOUS RESULTS. NO PATIENT IMPACT WAS REPORTED. REPORT 3 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214697 KIESTRA MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT JTC BD KIESTRA LAB AUTOMATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other