BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA INOQULA

    MDR report key: 22628035 · Received July 28, 2025

    Report

    Report Number
    3010141591-2025-00003
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 29, 2025
    Report Date
    September 10, 2025
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472023
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: .

    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 CUSTOMER REPORTED AN ISSUE WITH THE BI-PLATES. NO OTHER ISSUES WERE REPORTED. DURING THE INVESTIGATION, THE FIELD SERVICE ENGINEER (FSE) IDENTIFIED A BI-PLATE ISSUE CAUSED BY A LOOSE AND MISALIGNED COMPARTMENT SENSOR. THE INOQULA SERVICE GUIDE SECTION 9.1.3.3.4, THE SENSOR ANGLE WAS PROPERLY ADJUSTED. TEST SAMPLES REVEALED INCORRECT DISPENSING TO THE SAME COMPARTMENT. THE FSE PERFORMED ALIGNMENT PER SECTION 4.5.3.5.3 (DISPENSE POSITION), 9.1.3.5.3 (PIPETTE TIP TEACH), AND 9.1.3.6.2 (DISPENSE LOCATION VERIFICATION). AFTER RUNNING 20 SUCCESSFUL TEST SAMPLES, THE SYSTEM WAS CONFIRMED TO BE FUNCTIONING CORRECTLY. THE UNIT WAS RETURNED TO PRODUCTION AND IS OPERATING AS EXPECTED. 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA HAS BEEN FOUND PRODUCING POTENTIAL INCORRECT RESULTS. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD KIESTRA INOQULA HAS BEEN FOUND PRODUCING POTENTIAL INCORRECT RESULTS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455460 BD KIESTRA INOQULA DEVICE, MICROTITER DILUTING/DISPENSING JTC BD KIESTRA LAB AUTOMATION 00382904472023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other