BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA INOQULA

    MDR report key: 22926873 · Received August 29, 2025

    Report

    Report Number
    3010141591-2025-00005
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 6, 2025
    Report Date
    September 29, 2025
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472023
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION OF A COMPLAINT INVOLVING THE INSTRUMENT BD KIESTRA INOQULA. ACCORDING TO THE INFORMATION PROVIDED, THE INOQULA SYSTEM INCORRECTLY PROCESSED THREE URINE SAMPLES, POSSIBLY DUE TO CONTAMINATION. NO OTHER ISSUES WERE REPORTED. DURING THE INVESTIGATION, THE FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE INOQULA SYSTEM INCORRECTLY PROCESSED THREE URINE SAMPLES, POSSIBLY DUE TO CONTAMINATION. THE CLIENT IDENTIFIED THE ISSUE AS CONTAMINATION FROM AN ISOLATED SAMPLE AND CONFIRMED PLANS TO PROCEED WITH SEQUENCING. THE FSE CONTACTED THE APPLICATIONS TEAM FOR FOLLOW-UP AND PROVIDED CLEANING GUIDELINES FOR THE INOQULA SYSTEM. UPON FURTHER FOLLOW-UP, THE CLIENT CONFIRMED THAT THE CONTAMINATION ORIGINATED FROM ANOTHER INSTRUMENT. THE INOQULA SYSTEM WAS VERIFIED TO BE OPERATIONAL AND FUNCTIONING CORRECTLY ACCORDING TO BD PERFORMANCE CRITERIA. FOLLOWING THIS ACTION, NO FURTHER ISSUES WERE ENCOUNTERED. BASED ON 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. D4: MEDICAL DEVICE EXPIRATION DATE: N/A.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130871 BD KIESTRA INOQULA DEVICE, MICROTITER DILUTING/DISPENSING JTC BD KIESTRA LAB AUTOMATION 00382904472023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other