BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 18383820 · Received December 22, 2023

    Report

    Report Number
    1119779-2023-01424
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    November 10, 2023
    Report Date
    January 18, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH UNKNOWN. THE CUSTOMER NOTED MISIDENTIFICATIONS OF ESCHERICHIA COLI AS CITROBACTER FARMERI WHEN USING NMIC/ID-307. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS, ISOLATE RETURNS, PHOENIX GENERATED LAB REPORTS OR BINARY FILES FOR THE INVESTIGATION. AFTER MULTIPLE FOLLOW UPS, THE CUSTOMER STATED THAT "WE DON¿T HAVE THE TIME TO COMPLETE THE EXTENSIVE INFORMATION THAT YOU ARE REQUESTING, AS WE SEE DISCREPANCIES WITH ALL PANELS AND REAGENTS THAT WAS ALREADY DETERMINED." SINCE A BATCH NUMBER WAS NOT PROVIDED, FUNCTIONAL TESTING WITH RETENTION SAMPLES COULD NOT BE PERFORMED AS PART OF THE INVESTIGATION. THEREFORE, THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR A PANEL PERFORMANCE ISSUE. A REVIEW OF QUALITY NOTIFICATIONS COULD NOT BE PERFORMED SINCE A BATCH NUMBER WAS NOT PROVIDED. A REVIEW OF COMPLAINTS COULD NOT BE PERFORMED SINCE A BATCH NUMBER WAS NOT PROVIDED. COMPLAINT TRENDING WAS PERFORMED AND NO CURRENT TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Additional Manufacturer Narrative · 0

    UNKNOWN LOT NUMBER: D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. BD PHOENIX NMIC/ID-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: G5. PMA / 510(K)#: K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE WAS MISIDENTIFIED AS CITROBACTER FARMERI ON ITS INITIAL TESTING, IT THEN IDENTIFIED AS E. COLI WHEN RETESTED. THE EXPECTED RESULT WAS E. COLI. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PANEL PHOENIX NMIC/ID-307 A PATIENT ISOLATE WAS MISIDENTIFIED AS CITROBACTER FARMERI ON ITS INITIAL TESTING, IT THEN IDENTIFIED AS E. COLI WHEN RETESTED. THE EXPECTED RESULT WAS E. COLI. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298896 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) UNKNOWN 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown