BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 18247760 · Received December 1, 2023

    Report

    Report Number
    1119779-2023-01298
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    October 28, 2023
    Report Date
    January 31, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    K181665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS ENTEROBACTER CLOACAE WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 3213335. THE CUSTOMER DID NOT RETURN ISOLATES OR PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOW A PATIENT ISOLATE IDENTIFIED AS E. COLI AND E. CLOACAE ON THE COMPLAINT BATCH. TO INVESTIGATE, THREE RETENTION PANELS FROM COMPLAINT BATCH 3213335 WERE TESTED USING IN HOUSE ISOLATE E. COLI ENF9924 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, TWO CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATE E. COLI ENF9924 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE FIVE PANELS TESTED IDENTIFIED THE ISOLATE AS E. COLI, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. ALTHOUGH WE DIDN'T SEE THE ISSUE DURING COMPLAINT INVESTIGATION TESTING, WE RECOGNIZED THROUGH COMPLAINT TRENDING AN INCREASE OF E. COLI MIS IDS OVER THE PAST YEAR. THE TECHNICAL TEAM HAS IDENTIFIED A POTENTIAL ENHANCEMENT THAT WOULD BOLSTER THE INSTRUMENT¿S ABILITY TO INTERPRET THE BEHAVIOR OF THE ORGANISM¿S INTERACTION WITH THE SUBSTRATES ON THE PANEL. THE BATCH HISTORY RECORD WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED TEN ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 3213335, RELATED TO THIS DEFECT AND UNCONFIRMED AND ALL FROM THE SAME CUSTOMER. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT.

    Additional Manufacturer Narrative · 0

    H.3. 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

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307, THERE WAS MISIDENTIFICATION OF ONE PATIENT SAMPLE. NO PATIENT IMPACT OR TREATMENT CHANGE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307, THERE WAS MISIDENTIFICATION OF ONE PATIENT SAMPLE. NO PATIENT IMPACT OR TREATMENT CHANGE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454188 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3213335 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown