BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PMIC/ID-107

    MDR report key: 12166886 · Received July 14, 2021

    Report

    Report Number
    1119779-2021-01168
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 16, 2021
    Report Date
    September 10, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904486076
    PMA / PMN Number
    K040106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-06-28. H6: INVESTIGATION SUMMARY THIS COMPLAINT IS FOR THE MIS-IDENTIFICATION OF STAPHYLOCOCCUS SAPROPHYTICUS AS STAPHYLOCOCCUS HOMINIS WHEN USING PHOENIX PANEL PMIC/ID 107 (448607) BATCH NUMBERS 0210485 AND 0342594. THE CUSTOMER RETURNED TWO PANELS, ONE ISOLATE, AND THREE ID BROTHS FOR INVESTIGATION. TO INVESTIGATE, A TOTAL OF SIX PANELS WERE TESTED USING A PHOENIX M50 INSTRUMENT AND CUSTOMER RETURNED ISOLATES OF STAPHYLOCOCCUS SAPROPHYTICUS AND EVALUATED FOR IDENTIFICATION RESULTS. TWO OF THE TESTED PANELS WERE CUSTOMER RETURNED PANELS AND THE REMAINING PANELS WERE PULLED FROM RETENTION. ONE PANEL WAS A CONTROL PANEL FROM THE SAME CATALOG NUMBER, BUT DIFFERENT BATCH. DURING INVESTIGATION, ALL SIX PANELS IDENTIFIED INCORRECTLY AS STAPHYLOCOCCUS HOMINIS. ADDITIONALLY, MALDI WAS PERFORMED TO CONFIRM THE IDENTIFICATION OF THE CUSTOMER RETURNED ISOLATE AND YIELDED A RESULT OF STAPHYLOCOCCUS SAPROPHYTICUS. SINCE THE INVESTIGATION RESULTS WERE UNSATISFACTORY, THIS COMPLAINT IS CONFIRMED. MOVING FORWARD WE WILL CONTINUE TO MONITOR FOR TRENDS ON THIS DEFECT. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THE COMPLAINT BATCHES.   A REVIEW OF COMPLAINTS REVEALED FOUR ADDITIONAL COMPLAINTS FOR COMPLAINT BATCH 0210485 AND TWO ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 0342594. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ PMIC/ID-107 2 MISIDENTIFICATIONS WERE OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT CUSTOMER IS REPORTING (2) MIS-IDS ON THEIR PHOENIX PMIC/ID PANEL, LOTS 0210485 AND 0342594. "

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0342594 MEDICAL DEVICE EXPIRATION DATE: 2021-12-31 DEVICE MANUFACTURE DATE: (B)(6) 2020 MEDICAL DEVICE LOT #: 0210485 MEDICAL DEVICE EXPIRATION DATE: 2021-08-31 DEVICE MANUFACTURE DATE: (B)(6) 2020 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¿ PMIC/ID-107 2 MISIDENTIFICATIONS WERE OBSERVED BY THE LABORATORY PERSONNEL. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT CUSTOMER IS REPORTING (2) MIS-IDS ON THEIR PHOENIX PMIC/ID PANEL, LOTS 0210485 AND 0342594. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066659 BD PHOENIX PMIC/ID-107 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 448607 SEE H.10. 30382904486076

    Patients

    Seq Age Sex Outcome Treatment
    1