BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA INOQULA TRACK

    MDR report key: 23837184 · Received December 18, 2025

    Report

    Report Number
    3010141591-2025-00012
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 27, 2025
    Report Date
    January 13, 2026
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904469726
    PMA / PMN Number
    EXEMPT
    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.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 APPEAR TO HAVE BEEN SOME DISCREPANT GROWTH PATTERNS BETWEEN DIFFERENT PLATES FOR THE SAME SAMPLE. NO OTHER ISSUES WERE REPORTED. DURING THE INVESTIGATION, THE SYSTEM SERVICE ENGINEER (SSE) CONNECTED AND OBSERVED DISCREPANT GROWTH PATTERNS BETWEEN DIFFERENT PLATES FOR THE SAME SAMPLE. THE DISHES MENTIONED BY THE CUSTOMER WERE CHECKED, AND LOGS WERE REVIEWED; NO RELATED ERRORS WERE FOUND. LATER, UPON ARRIVAL, THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE INOQULA SYSTEM IN PRODUCTION WITH LIVE SAMPLES. PIPETTE ASPIRATE/DISPENSE HEIGHTS WERE VERIFIED AND APPEARED CORRECT, DISPENSING SAMPLES PROPERLY. A SMALL SECTION OF THE SA SPREADER WORK SURFACE WAS SLIGHTLY STICKY, WHICH WAS CLEANED BEFORE CONTINUING MONITORING. MECHANICALLY, EVERYTHING APPEARED TO BE FUNCTIONING CORRECTLY. A CASE HAS BEEN RAISED TO DETERMINE THE POSSIBLE CAUSE OF THE REPORTED DISCREPANT GROWTH PATTERNS. THE CUSTOMER WAS ADVISED TO RECORD ANY FURTHER OCCURRENCES AND NOTE SAMPLE NUMBERS. NO OTHER ISSUES WERE REPORTED, AND THE INSTRUMENT WAS LEFT OPERATIONAL IN PRODUCTION. ADDITIONALLY, THE TIP WAS NOTED TO BE TOUCHING THE AUGER DURING ASPIRATION; ASPIRATION HEIGHT WAS ADJUSTED. THE INSTRUMENT NOW PERFORMS TO SPECIFICATIONS AND IS READY FOR ROUTINE USE WITHOUT RESTRICTIONS. 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. D.4. MEDICAL DEVICE EXPIRATION DATE: N/A.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA TRACK HAS BEEN FOUND PRODUCING INCORRECT RESULTS. NO PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA TRACK HAS BEEN FOUND PRODUCING INCORRECT RESULTS. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246314 BD KIESTRA INOQULA TRACK MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT JTC BD KIESTRA LAB AUTOMATION 00382904469726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other