BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AP

    MDR report key: 15460011 · Received September 20, 2022

    Report

    Report Number
    1119779-2022-01212
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    September 6, 2022
    Report Date
    March 15, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQX
    UDI-DI
    00382904480103
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE NUMBER: (B)(6). 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

    H.6 INVESTIGATION SUMMARY THE COMPLAINT OF "ATB RESULTS INCONSISTENT " WAS RECEIVED AGAINST INSTRUMENT PHOENIX AP MATERIAL NUMBER: 448010, SERIAL NUMBER: (B)(6). BD REMOTE ASSISTANCE PROVIDED, INSTRUCTED CUSTOMER TO PERFORM A DECONTAMINATION OF THE INSTRUMENT AND CHANGE THE DISPENSING TUBE. WHICH RESOLVED THE ISSUE. INSTRUMENT WAS FOUND TO BE OPERATIONAL AND RELEASED TO THE CUSTOMER FOR REGULAR USE. THIS COMPLAINT IS AN UNCONFIRMED FAILURE OF THE BD PRODUCT. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS NO MATERIALS WERE RECEIVED FOR INVESTIGATION. DEVICE HISTORY RECORD REVIEW FOR THE INSTRUMENT (B)(6), IS NOT REQUIRED FOR THIS COMPLAINT AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND THE CONFIGURATION HAS CHANGED SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. SERVICE HISTORY REVIEW WAS PERFORMED FOR THIS INSTRUMENT AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION AND THUS, RETURNED MATERIAL INVESTIGATION COULD NOT OCCUR. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    AN UPDATE TO THE H TAB HAS BEEN ADDED: ANNEX E, F AND A CODES HAVE BEEN ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE FALSE RESISTANCE WITH BD PHOENIX¿ AP. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: THE CUSTOMER CALLS BECAUSE THE ATBS OF THE PANELS PREPARED WITH THE AP OFTEN APPEAR RESISTANT TO CARBAPENEMS AND RESULTS INCONSISTENT WITH THE REST OF THE RESULTS OF THE ATBS. REPEATED MANUALLY, THE PANELS ARE SENSITIVE TO CARBAPEMENS. THE GILESSPIE APPLICATION SPECIALIST WAS INFORMED AND THE CUSTOMER WAS ADVISED TO PERFORM A DECONTAMINATION OF THE AP INSTRUMENT AND CHANGE THE DISPENSING TUBE. THE CUSTOMER USES TWO TYPES OF PANELS REF (B)(4) LOT 2110769 AND REF (B)(4) LOT 2081450. THE CUSTOMER IS NOT ABLE TO PROVIDE AT THE MOMENT THE LOT NUMBER OF THE INDICATOR. THE CUSTOMER NOTICED A DIFFERENCE IN THE MEASUREMENT OF THE MANUAL MCF AND WITH THE TUBE DILUTED BY THE AP.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE FALSE RESISTANCE WITH BD PHOENIX¿ AP. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: " THE CUSTOMER CALLS BECAUSE THE ATBS OF THE PANELS PREPARED WITH THE AP OFTEN APPEAR RESISTANT TO CARBAPENEMS AND RESULTS INCONSISTENT WITH THE REST OF THE RESULTS OF THE ATBS. REPEATED MANUALLY, THE PANELS ARE SENSITIVE TO CARBAPEMENS. THE GILESSPIE APPLICATION SPECIALIST WAS INFORMED AND THE CUSTOMER WAS ADVISED TO PERFORM A DECONTAMINATION OF THE AP INSTRUMENT AND CHANGE THE DISPENSING TUBE. THE CUSTOMER USES TWO TYPES OF PANELS REF 448876 LOT 2110769 AND REF 448874 LOT 2081450. THE CUSTOMER IS NOT ABLE TO PROVIDE AT THE MOMENT THE LOT NUMBER OF THE INDICATOR. THE CUSTOMER NOTICED A DIFFERENCE IN THE MEASUREMENT OF THE MANUAL MCF AND WITH THE TUBE DILUTED BY THE AP."

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE FALSE RESISTANCE WITH BD PHOENIX¿ AP. THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: " THE CUSTOMER CALLS BECAUSE THE ATBS OF THE PANELS PREPARED WITH THE AP OFTEN APPEAR RESISTANT TO CARBAPENEMS AND RESULTS INCONSISTENT WITH THE REST OF THE RESULTS OF THE ATBS. REPEATED MANUALLY, THE PANELS ARE SENSITIVE TO CARBAPEMENS. THE GILESSPIE APPLICATION SPECIALIST WAS INFORMED AND THE CUSTOMER WAS ADVISED TO PERFORM A DECONTAMINATION OF THE AP INSTRUMENT AND CHANGE THE DISPENSING TUBE. THE CUSTOMER USES TWO TYPES OF PANELS REF 448876 LOT 2110769 AND REF (B)(4), LOT 2081450. THE CUSTOMER IS NOT ABLE TO PROVIDE AT THE MOMENT THE LOT NUMBER OF THE INDICATOR. THE CUSTOMER NOTICED A DIFFERENCE IN THE MEASUREMENT OF THE MANUAL MCF AND WITH THE TUBE DILUTED BY THE AP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2714667 BD PHOENIX¿ AP NEPHELOMETER, FOR CLINICAL USE JQX BECTON, DICKINSON & CO. (SPARKS) 448010 00382904480103

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown