BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD PHOENIX¿ PMIC/ID 69

    MDR report key: 7562679 · Received February 1, 2016

    Report

    Report Number
    1119779-2018-00009
    Event Type
    Death
    Date Received
    February 1, 2016
    Date of Event
    December 28, 2015
    Report Date
    January 20, 2016
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    LON
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MIS-ID OF S. AUREUS AS S. EPIDERMIDIS WHEN USING PHOENIX PANEL (B)(4) BATCH 7341912. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF QUALITY NOTIFICATIONS FOR THE BATCH. NO QUALITY NOTIFICATIONS WERE NOTED ON THE BATCH. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED FOR THIS DEFECT (MIS-ID OF S. AUREUS AS S. EPIDERMIDIS). ISOLATES AND RESULT REPORTS WERE RECEIVED FROM THE CUSTOMER (NO PANEL RETURNS RECEIVED). ALL PHOENIX PANELS USED TO INVESTIGATE THE COMPLAINT WERE IN-HOUSE RETENTION PANELS. COMPLAINT TESTING: QC ATCC 29213 WAS RUN ON M50 AND PHOENIX 100 AND YIELDED THE EXPECTED RESULT (STAPH AUREUS). PANELS TESTED WERE FROM COMPLAINT BATCH 7341912. TESTED COMPLAINT BATCH 7341912 ALONGSIDE CONTROL PANEL PQC01 BATCH 8038540 WITH RETURNED ISOLATES ON M50 AND PHOENIX 100. FOR EACH OF THE 12 PANELS TESTED, PHOENIX IDENTIFIED THE ISOLATES AS S. EPIDERMIDIS. ISOLATED THE RETURNED ISOLATES AND RECOVERED FOUR COLONIES. THE FOUR ISOLATED COLONIES DIFFERED IN APPEARANCE (WHITE, SMALL, GREY AND FLATTISH GREY-WITH THE TWO GREY COLONIES LIKELY BEING THE SAME). THE FOUR COLONIES WERE RUN ON MALDI AND ALL WERE IDENTIFIED AS S. AUREUS. TESTED COMPLAINT BATCH 7341912 ALONGSIDE CONTROL PANEL PID BATCH 7340620 WITH RETUNED ISOLATED COLONIES ON M50 AND PHOENIX IDENTIFIED ALL COLONIES AS S. EPIDERMIDIS. THIS COMPLAINT IS CONFIRMED FOR MIS-ID OF S. AUREUS AS S. EPIDERMIDIS DUE TO THE ATYPICAL NATURE OF THE STRAINS SUBMITTED. THERE IS NO EVIDENCE OF A PRODUCT DEFECT. INVESTIGATION CONCLUSION: ISOLATES AND RESULT REPORTS WERE RECEIVED FROM THE CUSTOMER (NO PANEL RETURNS RECEIVED). PHOENIX IDENTIFIED THE RETURNED ISOLATES AND COLONIES AS S. EPIDERMIDIS. CONFIRMATORY MALDI TESTING IDENTIFIED RETURNED COLONIES AS S. AUREUS. THIS COMPLAINT IS CONFIRMED FOR MIS-ID OF S. AUREUS AS S. EPIDERMIDIS DUE TO THE ATYPICAL NATURE OF THE STRAINS SUBMITTED. THERE IS NO EVIDENCE OF A PRODUCT DEFECT. NO COMPLAINT TREND EXISTS FOR THIS DEFECT (MIS-ID OF S. AUREUS AS S. EPIDERMIDIS). THEREFORE, NO FURTHER CORRECTIVE ACTION IS REQUIRED. BD ID/AST PLANT QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS DEFECT. ROOT CAUSE DESCRIPTION: ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ERRONEOUS RESULTS (WRONG IDENTIFICATION OF BACTERIA) OCCURED FROM A BD PHOENIX¿ PMIC/ID 69. THE CUSTOMER DID NOT RELY ON BD PHOENIX INSTRUMENT RESULT, NOR WAS THERAPY GIVEN BASED ON BD PHOENIX INSTRUMENT RESULT BUT BASED ON OTHER RESULTS GIVEN BY ALTERNATIVE METHODS. PATIENT DIED BUT NOT RELATED TO TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59583 BD PHOENIX¿ PMIC/ID 69 IDENTIFICATION AND SUSCEPTIBILITY TESTING LON BECTON, DICKINSON & CO. 7341912

    Patients

    Seq Age Sex Outcome Treatment
    1 Death