BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 11959207 · Received June 8, 2021

    Report

    Report Number
    1119779-2021-00957
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 10, 2021
    Report Date
    November 15, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904436247
    PMA / PMN Number
    K131331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 5/14/2021. H.6. INVESTIGATION: A READING ACCURACY FAILURE WAS REPORTED ON A PHOENIXSPEC NEPHELOMETER (P/N 440910, S/N (B)(6) ) ASSOCIATED WITH A PHOENIX M50 INSTRUMENT (P/N 442624, S/N (B)(6) ). THE CUSTOMER REPORTED THAT THE NEPHELOMETER WAS PROVIDING INACCURATE TURBIDITY READINGS, STATING THAT THE CALIBRATION WAS ABLE TO BE PERFORMED ACCURATELY, WITH NO ERRORS, BUT WHEN TESTING PATIENT SAMPLES, THE READINGS WERE OUTSIDE OF EXPECTATIONS. THE CUSTOMER COMPARED THE MCFARLAND READINGS OF S/N (B)(6) WITH THE SAME SAMPLE READINGS ON THREE OTHER NEPHELOMETERS AS WELL AS A PHOENIX AP INSTRUMENT (P/N 440810, S/N AP0721). BD REMOTE SERVICES WALKED THE CUSTOMER THROUGH A VISUAL INSPECTION OF THE NEPHELOMETER, CHECKING THE INSTRUMENT FOR DEBRIS SUCH AS STRAY CAPS OR LABELS IN THE TUBE HOLDER, BUT NONE WERE FOUND. THE CALIBRATION TUBES IN USE WITH THE INSTRUMENT WERE VERIFIED TO BE WITHIN THEIR EXPIRATION. BD REMOTE SERVICES ADVISED THE CUSTOMER TO POWER CYCLE THE NEPHELOMETER AND CALIBRATE AND READ THE CALIBRATION TUBES. RESULTS WERE WITHIN EXPECTATION. THE CUSTOMER PREPARED A HOMOGENOUS CANDIDA SPECIMEN, AND THE READING WAS 0.93 MCF. THE SAMPLE WAS READ ON THE THREE OTHER NEPHELOMETERS, AS WELL AS THE PHOENIX AP, WITH ALL GIVING A READING OF 1.79 MCF. NO ERRORS WERE GIVEN BY THE NEPHELOMETER. YEAST SPECIMENS, INCLUDING HOMOGENOUS CANDIDA, ARE TO BE PREPARED AT 2.0 MCF. AT 2.0 MCF, THE EXPECTED ACCURACY OF THE NEPHELOMETER IS +/- 20%. AS THE READINGS WERE NOT WITHIN THIS SPECIFICATION, A REPLACEMENT NEPHELOMETER WAS PROVIDED TO THE CUSTOMER AND A RETURN OF THE FAULTY NEPHELOMETER WAS REQUESTED. THE BD FIELD SERVICE ENGINEER (FSE) WHO WORKED WITH THE CUSTOMER ON THIS COMPLAINT WAS INTERVIEWED AS PART OF THE INVESTIGATION. THE FSE REPORTED THAT THE CUSTOMER WAS UNABLE TO IDENTIFY AN EVENT OR DATE THAT LED TO THIS FAILURE MODE. THE FAILURE WAS IDENTIFIED BY A LAB TECHNICIAN WHO QUESTIONED THE ACCURACY BASED ON COMPARISON OF THE VISUAL TURBIDITY OF THE TUBE TO THE READING GIVEN BY THE NEPHELOMETER. NO GRAM NEGATIVE OR GRAM POSITIVE (GN/GP) ISOLATES WERE CONSIDERED BY THE CUSTOMER TO BE AFFECTED, AS THESE WERE BEING PREPARED BY THE PHOENIX AP. YEAST PANELS ARE NOT COMPATIBLE WITH THE AP; THIS WAS THE REASON WHY THIS SAMPLE OF CANDIDA WAS PREPARED ON THE NEPHELOMETER ALONE. NO YEAST RESULTS HAD RECENTLY BEEN CONSIDERED AS MIS-IDS OR REQUIRED CORRECTION OF RESULTS. ONLY ONE RESULT HAD BEEN QUESTIONED, AND THE IDENTIFICATION OF THIS ISOLATE WAS CONFIRMED AS ACCURATE WHEN SENT TO A REFERENCE LABORATORY. THE CUSTOMER REPORTED THAT THE REPLACEMENT NEPHELOMETER PROVIDED TO THEM WAS READING ACCURATELY WHEN COMPARED TO THEIR PHOENIX AP, AND THEY WERE NOT EXPERIENCING ANY OTHER ERRORS WITH ITS USAGE. THE INVESTIGATION INTO THE NEPHELOMETER WAS COMPLETED WITH A RETURN OF THE DEVICE TO BD. CALIBRATION OF THE NEPHELOMETER IS DESIGNED BASED UPON THE STANDARD READING OF E. COLI SAMPLES; AS SUCH, BD R&D PREPARED AN E. COLI SAMPLE AT 0.5 MCF. THE RETURNED NEPHELOMETER WAS CALIBRATED, AND THE 0.5 MCF SAMPLE WAS READ AS 0.5 MCF. A REFERENCE YEAST SAMPLE WAS PREPARED AT 2.0 MCF AND READ WITHIN THE 20% SPECIFICATION LIMIT. NO FAILURE OF THIS NEPHELOMETER WAS OBSERVED. BASED UPON THIS INVESTIGATION, THIS IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. REVIEW OF A DEVICE HISTORY RECORD (DHR) WAS COMPLETED BY REVIEWING INCOMING INSPECTION RECORDS; THIS DEVICE WAS RECEIVED AND PASSED CALIBRATION REQUIREMENTS USING A MIXED-BATCH CALIBRATION KIT AS REQUIRED (0.25 MCF, 18064914; 1.0 MCF, 18064915, 4.0 MCF 18065061) IN JUNE OF 2018, SUCCESSFULLY READING CALIBRATION TUBES FROM A SEPARATE LOT AT 0.25, 0.50, 1.0, 2.0, AND 4.0 MCF. SERVICE HISTORY FOR THIS CUSTOMER WAS REVIEWED FOR ANY COMPLAINTS ASSOCIATED WITH THIS NEPHELOMETER. IT IS NOTED THAT THE CUSTOMER REPORTED ¿CAL?¿ ERRORS ON THREE OTHER NEPHELOMETERS AT THE SAME TIME AS THE REPORT OF THIS INCORRECT READING. THE CUSTOMER DID NOT STATE IF THE ¿CAL?¿ ERROR WAS OCCURRING ON THE SAME NEPHELOMETERS THAT WERE COMPARED TO THE NEPHELOMETER WITH THE INCORRECT READING. THERE WERE NO FURTHER COMPLAINTS FOR NEPHELOMETERS AGAINST EITHER OF THE PHOENIX M50 INSTRUMENTS REGISTERED TO THE CUSTOMER LOCATION (PF1784 AND PF1785), AND NO COMPLAINTS LISTED AGAINST THE S/N 3244 NEPHELOMETER ITSELF. THE ROOT CAUSE IS NOT KNOWN; NO FAILURE COULD BE CONFIRMED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM A MISIDENTIFICATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. " CUSTOMER PROBLEM: CUSTOMER REPORTS 440910 SERIAL NUMBER 3244 IS READING INACCURATELY.. ".

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM A MISIDENTIFICATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. CUSTOMER PROBLEM: CUSTOMER REPORTS (B)(4) SERIAL NUMBER (B)(4) IS READING INACCURATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853255 BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 443624 00382904436247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown