BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA¿ INOQULA+¿ TLA

    MDR report key: 17476505 · Received August 7, 2023

    Report

    Report Number
    3010141591-2023-00004
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 24, 2023
    Report Date
    November 14, 2023
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    JTC
    UDI-DI
    00382904472139
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE BD KIESTRA INOQULA TLA. ACCORDING TO THE INFORMATION PROVIDED, THE CUSTOMER HAD REPORTED THAT THE INOQULA 1 WAS SCANNING INCORRECTLY. DURING THE INVESTIGATION, IT WAS FOUND THAT THE INOQULA SCANNER WAS NOT READING THE ACCESSION NUMBER CORRECTLY. INSTEAD OF SCANNING (B)(6). , IT WAS DISPLAYING (B)(6). . THE SYSTEM SUPPORT ENGINEER (SSE) LOGGED INTO THE SYSTEM AND RESTARTED THE KIESTRA LAB AUTOMATION (KLA) SERVICES, AND THE CUSTOMER RESTARTED THE LABORATORY INFORMATION SYSTEM (LIS) SERVICES. THE SSE VERIFIED THE LIS COMMUNICATIONS, WHICH WERE RUNNING WITHOUT ERRORS. ONLY THIS ONE SAMPLE WAS FOUND TO BE SCANNED INCORRECTLY. A ROOT CAUSE WAS NOT IDENTIFIED. THERE WERE NO ADVERSE EFFECTS OR RESULTS FROM THE SCANNING ERROR. THE OPERATOR WAS ABLE TO MANUALLY RESCAN THE SAMPLE, WHICH PREVENTED THE SAMPLE FROM BEING PROCESSED INCORRECTLY. 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. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS ISSUE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD KIESTRA¿ INOQULA+¿ TLA, THERE WAS MISASSOCIATION OF ONE ACCESSION NUMBER. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INOQULA SCANNING ASCESSION NUMBER INCORRECTLY. SCANNING (B)(6). THERE WERE NO ADVERSE EFFECTS OR RESULTS FROM THE MISS SCANNING. THE OPERATOR WAS ABLE TO SCAN THE SAMPLES MANUALLY AND PREVENT THE SAMPLE FROM BEING PROCESSED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD KIESTRA¿ INOQULA+¿ TLA, THERE WAS MISASSOCIATION OF ONE ACCESSION NUMBER. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INOQULA SCANNING ASCESSION NUMBER INCORRECTLY. SCANNING (B)(6) AND SHOWING (B)(6). THERE WERE NO ADVERSE EFFECTS OR RESULTS FROM THE MISS SCANNING. THE OPERATOR WAS ABLE TO SCAN THE SAMPLES MANUALLY AND PREVENT THE SAMPLE FROM BEING PROCESSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699425 BD KIESTRA¿ INOQULA+¿ TLA MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT JTC BD KIESTRA LAB AUTOMATION 00382904472139

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown