BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AP

    MDR report key: 16221949 · Received January 23, 2023

    Report

    Report Number
    1119779-2023-00051
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    January 13, 2023
    Report Date
    March 7, 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

    H.6 INVESTIGATION SUMMARY: THE COMPLAINT OF "MANY ANTIBIOGRAMS ARE RESISTANT" WAS RECEIVED AGAINST INSTRUMENT PHOENIX AP MATERIAL NUMBER: 448010, SERIAL NUMBER: (B)(6). BD REMOTE ASSISTANCE PROVIDED AND INSTRUCTED CUSTOMER TO DECONTAMINATE THE INSTRUMENT, REMOVE ALL CONSUMABLES AND PROCESS THE TEST PANELS. 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.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY NAME: 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 THAT WHILE USING THE BD PHOENIX¿ AP THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AST INDICATOR: 2203730. BROTHBAG ID: 2032519. VIALS: ID: (B)(6). AST 4.5ML :2265728. AST 8.5ML :2160475. DISPENSER TUBE ID: (B)(6). ORGANISM AFFECTED: GRAM+: ENTEROCOCCUS FAECIUM. GRAM -: MORGANELLA MORGANII AND KLEBSIELLA PNEUMONIAE. (B)(4). THE CUSTOMER COMPLAINS OF AN INCREASE IN RESISTANCE RESULTS FROM SAMPLES PROCESSED ON THIS INSTRUMENT. THE CUSTOMER HAS NOTICED THAT THE PROBLEM DOES NOT EXIST WITH THE OTHER PREPARER AND SUSPECTS CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ AP THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AST INDICATOR: 2203730 BROTHBAG ID: 2032519. VIALS: ID:2244194 AST 4.5ML :2265728 AST 8.5ML :2160475. DISPENSER TUBE ID:4441704. ORGANISM AFFECTED: GRAM+: ENTEROCOCCUS FAECIUM. GRAM -: MORGANELLA MORGANII AND KLEBSIELLA PNEUMONIAE. PIERFRANCESCO NODALE : (B)(6)2023 11:01:29 (GMT) THE CUSTOMER COMPLAINS OF AN INCREASE IN RESISTANCE RESULTS FROM SAMPLES PROCESSED ON THIS INSTRUMENT. THE CUSTOMER HAS NOTICED THAT THE PROBLEM DOES NOT EXIST WITH THE OTHER PREPARER AND SUSPECTS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408198 BD PHOENIX¿ AP NEPHELOMETER, FOR CLINICAL USE JQX BECTON, DICKINSON & CO. (SPARKS) 448010 00382904480103

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown