BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-107

    MDR report key: 16225096 · Received January 23, 2023

    Report

    Report Number
    1119779-2023-00057
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    December 14, 2022
    Report Date
    May 25, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL PMIC/ID-107 (448607) BATCH NUMBERS 2060227, 2207540 AND 0130382. BATCH 0130382 DOES NOT EXIST FOR THIS PANEL MATERIAL #448607 AND WAS NOT INVESTIGATED. THE CUSTOMER DID NOT RETURN PANELS OR PHOENIX GENERATED LAB REPORTS BUT PROVIDED FOUR (4) ISOLATES FOR THE INVESTIGATION. THE FOUR (4) CUSTOMER RETURNED ISOLATES WERE LABELED AS FL-1, FL-3, FL-5, AND FL-6. TO INVESTIGATE, EACH OF THE FOUR (4) CUSTOMER RETURNED ISOLATES WERE TESTED ON A PHOENIX M50 WITH A RETENTION PANELS FROM EACH THE COMPLAINT BATCHES 2060227 AND 2207540 FOR A TOTAL OF (8) PANELS TESTED AND EVALUATED FOR PHOENIX IDENTIFICATION RESULTS. FOR FURTHER INVESTIGATION, EACH CUSTOMER RETURNED ISOLATE FL-1, FL-3, FL-5, FL-6 WERE RAN ON A BRUKER MALDI FOR IDENTIFICATION RESULTS. BRUKER MALDI PROVIDED THE FOLLOWING RESULTS: ISOLATE FL-1 WAS IDENTIFIED AS S. DYSGALACTIAE ON THE BRUKER MALDI. IT IS TO BE NOTED THAT S. DYSGALACTIAE IS A MEMBER OF THE LANCEFIELD GROUPS C AND G. ISOLATE FL-3 WAS IDENTIFIED AS S. EPIDERMIDIS. ISOLATES FL-5 AND FL-6 WERE IDENTIFIED AS S. SAPROPHYTICUS. DURING THE INVESTIGATION, ALL EIGHT (8) PANELS TESTED YIELDED EXPECTED IDENTIFICATION RESULTS. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON EITHER OF THE COMPLAINT BATCHES 2207540 AND 2060227. A REVIEW OF COMPLAINTS REVEALED THREE (3) ADDITIONAL COMPLAINTS ON BATCH 2207540. NONE OF THE 3 ADDITIONAL COMPLAINTS ARE RELATED TO THIS DEFECT AND NONE HAVE BEEN CONFIRMED. A REVIEW OF COMPLAINTS REVEALED SEVEN (7) ADDITIONAL COMPLAINTS ON BATCH 2060227. OF THE SEVEN (7) ADDITIONAL COMPLAINTS, ONE (1) IS RELATED TO THIS DEFECT (MIS ID OF S. SAPROPHYTICUS) AND HAS BEEN CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS COULD NOT BE PERFORMED FOR BATCH 0130382 SINCE THE BATCH NUMBER WAS INVALID. A REVIEW OF COMPLAINTS FOR BATCH 0130382 COULD NOT BE PERFORMED SINCE THE BATCH NUMBER WAS INVALID. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT (MIS ID OF S. SAPROPHYTICUS) . BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    REPORTED 5 OF 5. IT WAS REPORTED THAT BD PHOENIX¿ PMIC/ID-107 MISIDENTIFICATION OCCURRED USING SEVERAL CLINICAL SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING MISIDENTIFICATION OF ORGANISMS USING 448607, LOT NUMBER 2207540 12/14/22-PHOENIX M50 ID AS STAPH PASTEURI BUT MALDI ID AS STAPH SAPRO.

    Description of Event or Problem · 0

    REPORTED 5 OF 5 IT WAS REPORTED THAT BD PHOENIX¿ PMIC/ID-107 MISIDENTIFICATION OCCURRED USING SEVERAL CLINICAL SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING MISIDENTIFICATION OF ORGANISMS USING 448607, LOT NUMBER 2207540 (B)(6)2022 -PHOENIX M50 ID AS STAPH PASTEURI BUT MALDI ID AS STAPH SAPRO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485001 BD PHOENIX¿ PMIC/ID-107 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 448607 2207540 30382904486076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown