BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 17255219 · Received July 5, 2023

    Report

    Report Number
    1119779-2023-00733
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 15, 2023
    Report Date
    August 14, 2023
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904481001
    PMA / PMN Number
    K020321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY A FAILURE FOR FALSE RESISTANCE WAS REPORTED ON A PHOENIX 100 INSTRUMENT (P/N 48100, S/N (B)(6)). THE CUSTOMER REPORTED THAT THEY HAD FALSE RESISTANCE ON TWO ISOLATES. S. AUREUS WAS TEICOPLANIN RESISTANT MIC=4 ON PHOENIX AND MIC=1 ON E TEST. P. MIRABILIS WAS AMC RESISTANT ON PHOENIX AND SENSITIVE ON DISC DIFFUSION. NO INSTRUMENT ISSUES WERE REPORTED THEREFORE THIS IS AN UNCONFIRMED FAILURE OF A BD PRODUCT. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. NO SAMPLES WERE EXPECTED TO BE RECEIVED AS PART OF THIS COMPLAINT, AND THEREFORE NO SAMPLES WERE RETURNED AND NO RETURNED MATERIAL INVESTIGATION COULD OCCUR. DHR REVIEW 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 FOR THIS INSTRUMENT WAS REVIEWED AND REVEALED NO PREVIOUS COMPLAINTS RELATED TO THIS FAILURE MODE. COMPLAINTS FOR RESULTS ARE WITHIN STATISTICAL CONTROL FOR THE MONTH OF JUNE 2023. THE UPPER CONTROL LIMIT WAS NOT BREACHED. QUALITY WILL CONTINUE TO MONITOR THE RESULTS COMPLAINTS FOR PHOENIX 100 INSTRUMENTS. NO NEW RISKS OR HAZARDS, OR CHANGES TO EXISTING RISKS/HAZARDS, WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, THERE WAS FALSE RESISTANCE OF ONE PANEL. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "S. AUREUS TEICOPLANIN RESISTANT ON PHOENIX (MIC=4). ON FURTHER TESTING USING E-TEST THE MIC WAS 1MG/L. PHOENIX ALSO CALLED AMC=R ON A PROTEUS MIRABILIS, WHICH WAS FULLY SENSITIVE ON DISC. WHICH PANELS WERE USED? PMIC LOT: 2285329, NMIC LOT 2263172. WHAT ARE THE LOT NUMBERS FOR THE KITS USED? AST INDICATOR: LOT 2298623 EXP 21/10/23, ID BROTH LOT 2280803 EXP 03/10/23, AST BROTH LOT 2216995 26/07/23".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM, THERE WAS FALSE RESISTANCE OF ONE PANEL. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "S. AUREUS TEICOPLANIN RESISTANT ON PHOENIX (MIC=4). ON FURTHER TESTING USING E-TEST THE MIC WAS 1MG/L. PHOENIX ALSO CALLED AMC=R ON A PROTEUS MIRABILIS, WHICH WAS FULLY SENSITIVE ON DISC. WHICH PANELS WERE USED? PMIC LOT: 2285329. NMIC LOT 2263172. WHAT ARE THE LOT NUMBERS FOR THE KITS USED? AST INDICATOR: LOT 2298623 EXP 21/10/23. ID BROTH LOT 2280803 EXP 03/10/23. AST BROTH LOT 2216995 26/07/23".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990406 BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 448100 00382904481001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown