BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PMIC/ID-107

    MDR report key: 16225075 · Received January 23, 2023

    Report

    Report Number
    1119779-2023-00055
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    November 7, 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

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL PMIC/ID-107. BATCH 0130382 DOES NOT EXIST FOR THIS PANEL MATERIAL #448607 AND WAS NOT INVESTIGATED.

    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 3 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 0130382 11/7/2022 - PHOENIX M50 ID AS STAPH AUREUS BUT MALDI ID AS STAPH SAPRO.

    Description of Event or Problem · 0

    REPORTED 3 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 0130382 (B)(6)2022 PHOENIX M50 ID AS (B)(6) BUT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568735 BD PHOENIX¿ PMIC/ID-107 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 448607 0130382 30382904486076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown