BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-306

    MDR report key: 11223184 · Received January 25, 2021

    Report

    Report Number
    1119779-2021-00134
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    December 21, 2020
    Report Date
    March 3, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    K151320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS COMPLAINT IS FOR FALSE RESISTANCE OF DRUGS ETP, CT, MEV AND MEM WHILE USING PHOENIX PANEL NMIC 306 (449292) BATCH 0294489. THE CUSTOMER DID NOT PROVIDE LAB REPORT RESULTS, PRODUCT OR ISOLATE RETURNS FOR INVESTIGATION. IT IS TO BE NOTED THAT A CONTAMINATION EVENT WITHIN THE CUSTOMER'S PHOENIX AP INSTRUMENT WAS FOUND, AND THAT THE ISSUE WAS RESOLVED AFTER DECONTAMINATION. TO INVESTIGATE, A TOTAL OF FIVE RETENTION PANELS WERE TESTED FOR THE FOLLOWING QC ISOLATES: A25922, A27853, A2518, A700603 AND A14780. THE FIVE PANELS TESTED EVERY ANTIBIOTIC ON THE PANEL, AND ALL QC ISOLATES YIELDED SATISFACTORY RESULTS PER THE PACKAGE INSERT FOR ALL MIC RESULTS. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THIS COMPLAINT BATCH. A REVIEW OF COMPLAINTS WAS PERFORMED AND THERE WERE NO ADDITIONAL COMPLAINTS FILED FOR THIS BATCH. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED FOR THIS DEFECT. BD ID/AST PLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD PANEL PHOENIX NMIC-306 THERE WAS FALSE RESISTANCE ON ERTAPENEM, CT, MEV AND MEM. ETEST RESULTED AS S. THERE WAS NO REPORTED PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: PMA / 510(K)#: K173252, K132674, K173523. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING WITH BD PANEL PHOENIX NMIC-306 THERE WAS FALSE RESISTANCE ON ERTAPENEM, CT, MEV AND MEM. ETEST RESULTED AS S. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120684 BD PANEL PHOENIX NMIC-306 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1