BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA¿ INOQULA+¿ TLA

    MDR report key: 13620672 · Received February 28, 2022

    Report

    Report Number
    3010141591-2022-00002
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 7, 2022
    Report Date
    January 31, 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
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: SERIAL NUMBER: (B)(4). BD TECHNICAL SERVICES STARTED THE INVESTIGATION. BY THE REVIEW OF LOG FILES, ISSUE COULD NOT BE REPRODUCED. AFFECTED DISHES WERE TRACKED FROM THE MOMENT OF CREATION AT THE BARCODA, INOCULATION AT THE INOQULA, AND INCUBATION/IMAGING AT THE READA COMPACT. ALL OF THESE PROCESSES OCCURRED SIMULTANEOUSLY WITHOUT ANY DELAY OR HUMAN INTERVENTION. INVESTIGATION CONFIRMED THAT POSITIVE DISPENSE VERIFICATION (PDV) WAS ACTIVATED FOR ALL OF THE ORIGINAL DISHES, CONFIRMING THAT ACTUAL INOCULUM WAS PIPETTED ONTO THE DISHES. THERE WAS NO OBSERVATION OF BD INSTRUMENT ERRORS AS INSTRUMENT WAS PERFORMING AS EXPECTED. THERE WERE NO REPORTS OF PATIENT IMPACT. COMPLAINT COULD NOT BE CONFIRMED. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED BECAUSE OF THIS COMPLAINT. DESIGN HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED FOR THIS COMPLAINT. THE COMPLAINT WAS EVALUATED VIA OTHER ELEMENTS OF THE INVESTIGATION. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD KIESTRA¿ INOQULA+¿ TLA PRODUCED FALSE POSITIVES ON TWO CULTURES PROCESSED THROUGH FA MODE, WITH ONE SAMPLE SHOWING 4+ GROWTH ON CNA, AND THE OTHER SHOWING 4+ GROWTH ON CHOCOLATE. HOWEVER, NO OTHER DISHES INOCULATED WITH THE SAMPLE SHOWED GROWTH. GRAM STAINS WERE DONE, PRODUCING NOS THE FIRST TIME, AND HEAVY GROWTH OF GNB THE NEXT. THERE WAS NO INDICATION THAT ERRONEOUS RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED ERRONEOUS RESULTS ON TWO CULTURES THAT WERE PROCESSED THROUGH FA MODE ON THE INOQULA. ON BOTH SAMPLES, THERE WAS 4+ GROWTH ON CNA BUT NO GROWTH ON ANY OF THE OTHER DISHES THAT WERE INOCULATED WITH THE SAMPLE. SAMPLES WERE: (B)(6)." "CORRECTION: ON SAMPLE (B)(6) THERE WAS 4+ GROWTH ON CNA. ON SAMPLE (B)(6) THERE WAS 4+ GROWTH ON CHOCOLATE." "THIS PAST WEEKEND, WE HAD A CULTURE THAT ONLY GREW RARE GNB ON ONE OF THE PLATES. WHEN WE RESET UP THE CULTURE, IS WAS HEAVY GROWTH OF GNB. THE GRAM STAIN ALSO WAS NOS THE FIRST TIME. RESET UP OF THE GRAM STAIN WAS GNB. THE SLIDE APPEARS TO HAVE BEEN MADE IN THE FA MODE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD KIESTRA¿ INOQULA+¿ TLA PRODUCED FALSE POSITIVES ON TWO CULTURES PROCESSED THROUGH FA MODE, WITH ONE SAMPLE SHOWING 4+ GROWTH ON CNA, AND THE OTHER SHOWING 4+ GROWTH ON CHOCOLATE. HOWEVER, NO OTHER DISHES INOCULATED WITH THE SAMPLE SHOWED GROWTH. GRAM STAINS WERE DONE, PRODUCING NOS THE FIRST TIME, AND HEAVY GROWTH OF GNB THE NEXT. THERE WAS NO INDICATION THAT ERRONEOUS RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED ERRONEOUS RESULTS ON TWO CULTURES THAT WERE PROCESSED THROUGH FA MODE ON THE INOQULA. ON BOTH SAMPLES, THERE WAS 4+ GROWTH ON CNA BUT NO GROWTH ON ANY OF THE OTHER DISHES THAT WERE INOCULATED WITH THE SAMPLE. SAMPLES WERE: (B)(6) "CORRECTION: ON SAMPLE (B)(6) THERE WAS 4+ GROWTH ON CNA. ON SAMPLE 1036183433 THERE WAS 4+ GROWTH ON CHOCOLATE." "THIS PAST WEEKEND, WE HAD A CULTURE THAT ONLY GREW RARE GNB ON ONE OF THE PLATES. WHEN WE RESET UP THE CULTURE, IS WAS HEAVY GROWTH OF GNB. THE GRAM STAIN ALSO WAS NOS THE FIRST TIME. RESET UP OF THE GRAM STAIN WAS GNB. THE SLIDE APPEARS TO HAVE BEEN MADE IN THE FA MODE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820436 BD KIESTRA¿ INOQULA+¿ TLA MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT JTC BD KIESTRA LAB AUTOMATION 447213 NA 00382904472139

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown