BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-311

    MDR report key: 18455459 · Received January 5, 2024

    Report

    Report Number
    1119779-2024-00005
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    November 1, 2023
    Report Date
    April 11, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904494520
    PMA / PMN Number
    SEE H10
    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 INFORMATION HAS BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL? YES D.9. RETURNED TO MANUFACTURER ON: 10-NOV-2023. H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR FALSE POSITIVE ESBL RESULTS WITH KLEBSIELLA OXYTOCA WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBERS 3241410 AND 3202514. THE CUSTOMER DID NOT PROVIDE ISOLATE RETURNS BUT PROVIDED PANEL RETURNS AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW POSITIVE ESBL RESULTS FOR K. OXYTOCA FROM A URINE AND SPUTUM SAMPLE WHEN USING THE COMPLAINT BATCH. IT IS TO BE NOTED THAT BATCH 3202514 IS AN ID ONLY PANEL AND THEREFORE DOES NOT TEST FOR ESBL RESULTS AND WAS NOT USED IN INVESTIGATION TESTING. TO INVESTIGATE, THREE CUSTOMER RETURNED PANELS EACH FROM COMPLAINT BATCH 3241410 WERE INOCULATED WITH IN HOUSE ISOLATES K. OXYTOCA 18410 AND K. OXYTOCA 18411 AND PLACED IN A PHOENIX M50 TO OBSERVE FOR ESBL RESULTS. ADDITIONALLY, ONE CONTROL PANEL EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES K. OXYTOCA 18410 AND K. OXYTOCA 18411 AND PLACED IN A PHOENIX M50 TO OBSERVE FOR ESBL RESULTS. DURING THE INVESTIGATION TESTING, THE EIGHT PANELS TESTED DID NOT RETURN ESBL POSITIVE RESULTS, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. THE BATCH HISTORY RECORDS WERE SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. A REVIEW OF COMPLAINTS REVEALED NO OTHER COMPLAINTS ON THIS BATCH. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Additional Manufacturer Narrative · 0

    G.5. PMA/510(K)#: THE PANEL PHOENIX NMIC/ID-311 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K061327, K031912, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K190905, K032655, K062944, K060444, K173252, K033362, K062207, K063811, K163637, K151320, K063301, K031530, K060447, K032567, K060257, K023634, K123404, K020322, K132674, K173523, K063486, K022129, K023858, K071623, K031699, K060447, K024153, K060214, K132909, K042932.H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: B3: DATE OF EVENT: 01-NOV-2023. B5: DESCRIBE EVENT: IT WAS REPORTED WHEN USING THE BD PANEL PHOENIX NMIC-311 A PATIENT SPUTUM ISOLATE (504522467920) WAS RESULTED AS POSITIVE FOR EXTENDED SPECTRUM BETA-LACTAMASE (ESBL). THE RESULT WAS CONFIRMED TO BE NEGATIVE BY KIRBY BAUER CULTURE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 3 OF 4. B6: RELEVANT TESTS/LABORATORY DATA: BACTERIAL CULTURE - KIRBY BAUER. D4: MEDICAL DEVICE LOT #: 3241410. D.4: MEDICAL DEVICE EXPIRATION DATE: 24-AUG-2024. H.4. DEVICE MANUFACTURE DATE: 29-AUG-2023.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PANEL PHOENIX NMIC-311 A PATIENT SPUTUM ISOLATE ((B)(6)) WAS RESULTED AS POSITIVE FOR EXTENDED SPECTRUM BETA-LACTAMASE (ESBL). THE RESULT WAS CONFIRMED TO BE NEGATIVE BY KIRBY BAUER CULTURE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    REPORT 3 OF 4.IT WAS REPORTED THAT DURING USE OF THE BD PANEL PHOENIX NMIC-311, THERE WAS FALSE POSITIVE ESBL ON K. OXYTOCA.THERE WAS NO ADVERSE IMPACT TO PATIENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PANEL PHOENIX NMIC-311 A PATIENT SPUTUM ISOLATE (504522467920) WAS RESULTED AS POSITIVE FOR EXTENDED SPECTRUM BETA-LACTAMASE (ESBL). THE RESULT WAS CONFIRMED TO BE NEGATIVE BY KIRBY BAUER CULTURE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687480 BD PANEL PHOENIX NMIC-311 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 3241410 00382904494520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown