BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 18257146 · Received December 4, 2023

    Report

    Report Number
    1119779-2023-01303
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    September 24, 2023
    Report Date
    February 6, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492892
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: B3: DATE OF EVENT FROM 10/01/2023 TO 09/24/2023 AND D4. MEDICAL DEVICE LOT #: 3213003 D4. MEDICAL DEVICE EXPIRATION DATE: 25-JUL-2024 H4. DEVICE MANUFACTURE DATE: 01-AUG-2023.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF PSEUDOMONAS ALCALIGENES AS ACHROMOBACTER SPP. WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 3103003. THE CUSTOMER DID NOT RETURN ISOLATES OR PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE CUSTOMER PROVIDED PHOENIX LAB REPORTS SHOWED P. ALCALIGENES AS ACHROMOBACTER SPP. WHEN USING THE COMPLAINT BATCH. BATCH 3213003 WAS UNAVAILABLE FOR INVESTIGATION TESTING AND A PANEL OF THE SAME MATERIAL WAS USED INSTEAD. IT IS TO BE NOTED THAT PHOENIX ID SYSTEMS DO NOT HAVE CLAIMS FOR P. ALCALIGENES. TO INVESTIGATE, TWO PANELS EACH FROM THE CONTROL BATCH WERE TESTED USING IN HOUSE ISOLATES P. AERUGINOSA ENF14319 AND P. AERUGINOSA ENF9516 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ADDITIONALLY, TWO PANELS FROM THE CONTROL BATCH WERE TESTED USING IN HOUSE ISOLATE P. AERUGINOSA A27853 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL SIX PANELS IDENTIFIED THEIR ISOLATES AS P. AERUGINOSA. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. WHILE THERE HAS BEEN AN OBSERVATION OF A PERFORMANCE FAILURE BY THE CUSTOMER, BD HAS NOT BEEN ABLE TO REPLICATE THE FAILURE THROUGH INVESTIGATIVE TESTING. THE BATCH HISTORY RECORD WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307, PSEUDOMONAS ALCALIGNES MISIDENTIFIED AS ACHROMOBACTER SPP. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307, PSEUDOMONAS ALCALIGNES MISIDENTIFIED AS ACHROMOBACTER SPP. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307, PSEUDOMONAS ALCALIGNES MISIDENTIFIED AS ACHROMOBACTER SPP. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504461 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3213003 00382904492892

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown