BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA IDENTIFA

    MDR report key: 23247882 · Received October 8, 2025

    Report

    Report Number
    3010141591-2025-00011
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 15, 2025
    Report Date
    March 2, 2026
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    QBN
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.2. MEDICAL DEVICE TYPE: QBN / QQV. D.4. MEDICAL DEVICE EXPIRATION DATE: N/A. G.5. PMA/510(K)#: K191964 / K222563.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION OF A COMPLAINT INVOLVING THE BD KIESTRA IDENTIFA. ACCORDING TO THE INFORMATION PROVIDED, THE CUSTOMER REPORTED THAT AN IDENTIFA CUVETTE LOADED ON THE SYSTEM CONTAINED SAMPLE DATA FROM APPROXIMATELY THREE MONTHS EARLIER. NO OTHER ISSUES WERE REPORTED. DURING THE INVESTIGATION, A TECHNICAL SOLUTIONS MANAGER (TSM) REVIEWED THE CUVETTE DATA IN SYNAPSYS AND CONFIRMED THAT THE SAMPLES ORIGINATED FROM MAY. SYNAPSYS AUDIT LOGS SHOWED CORRECT BEHAVIOR, AND IDENTIFA LOGS DID NOT SHOW ANY RECENT SCANS OF THIS CUVETTE. NO SYSTEM-RELATED MALFUNCTION WAS DETECTED. THE INVESTIGATION INDICATED THE ISSUE RESULTED FROM CUSTOMER WORKFLOW PRACTICES, AS CUVETTES WITH BARCODE SCANNING ISSUES HAD BEEN KEPT ASIDE, AND THE AFFECTED CUVETTE HAD BEEN MISPLACED INTO THAT GROUP. FOLLOWING THIS ACTION, NO FURTHER ISSUES WERE ENCOUNTERED. BASED ON THE INVESTIGATION, THIS CASE HAS BEEN ASSESSED AS UNCONFIRMED 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 HAS BEEN REPORTED THAT THE BD KIESTRA IDENTIFA HAS BEEN FOUND EXPERIENCING MISASSOCIATION OF SAMPLE DATA. NO PATIENT IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD KIESTRA IDENTIFA HAS BEEN FOUND EXPERIENCING MISASSOCIATION OF SAMPLE DATA. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2587108 BD KIESTRA IDENTIFA MICROBIAL SPECIMEN INOCULATION/STREAKING/COLONY-PICKING INSTRUMENT IVD QBN BD KIESTRA LAB AUTOMATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other