BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIESTRA¿ IDENTIFA

    MDR report key: 20887263 · Received December 9, 2024

    Report

    Report Number
    3010141591-2024-00008
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 30, 2024
    Report Date
    July 29, 2025
    Manufacturer
    BD KIESTRA LAB AUTOMATION
    Product Code
    QBN
    UDI-DI
    00382904440633
    PMA / PMN Number
    K191964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2. ADDITIONAL MEDICAL DEVICE TYPE: QQV. COMMON DEVICE NAME: AUTOMATED SYSTEM FOR SAMPLE PREPARATION AND IDENTIFICATION OF MICROORGANISMS FROM CULTURED ISOLATES BY MASS SPECTROMETRY G5. ADDITIONAL 510K: K222563. 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: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION OF A COMPLAINT INVOLVING THE BD KIESTRA IDENTIFA. ACCORDING TO THE INFORMATION PROVIDED, THE CUSTOMER REPORTED THAT THE MALDI SYSTEM GAVE INCORRECT BACTERIAL IDENTIFICATIONS AFTER THE TARGET PLATE WAS REMOVED FROM THE IDENTIFA SYSTEM. THESE MISIDENTIFICATIONS WERE CONFIRMED BY COMPARING THE MALDI RESULTS WITH MANUAL VERIFICATION USING THE VITEK SYSTEM, WHICH PROVIDED THE CORRECT BACTERIAL STRAINS. DURING THE INVESTIGATION, THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE MALDI SYSTEM HAD PREVIOUSLY PRODUCED INCORRECT RESULTS FOR SEVERAL ISOLATES. THE FSE PERFORMED MAINTENANCE ON THE DEVICE. UPON RE-EVALUATION, THE ISSUE COULD NOT BE REPRODUCED, AND NO NEW OCCURRENCES WERE REPORTED. BASED ON THIS, THE CASE WAS CLOSED. FOLLOWING THIS ACTION, NO FURTHER ISSUES WERE ENCOUNTERED. BASED ON THE INVESTIGATION, THIS CASE HAS BEEN ASSESSED AS CONFIRMED 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 WAS REPORTED THAT FOUR SPECIMENS THAT WERE PREPARED ON THE BD KIESTRA¿ IDENTIFA GAVE FALSE IDENTIFICATION RESULTS: ENTEROCOCCI WAS IDENTIFIED AS STAPHYLOCOCCUS. ENTEROCOCCI WAS IDENTIFIED AS ECOLI. PROTEUS WAS IDENTIFIED AS STAPH. HEMOLYTICUS. E. COLI WAS IDENTIFIED AS STR. CONSTELLATUS THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOUR SPECIMENS THAT WERE PREPARED ON THE BD KIESTRA¿ IDENTIFA GAVE FALSE IDENTIFICATION RESULTS: ENTEROCOCCI WAS IDENTIFIED AS STAPHYLOCOCCUS ENTEROCOCCI WAS IDENTIFIED AS ECOLI PROTEUS WAS IDENTIFIED AS STAPH. HEMOLYTICUS E. COLI WAS IDENTIFIED AS STR. CONSTELLATUS THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534783 BD KIESTRA¿ IDENTIFA SEE H11 QBN BD KIESTRA LAB AUTOMATION 00382904440633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown