BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX PMIC-110

    MDR report key: 24536611 · Received March 6, 2026

    Report

    Report Number
    1119779-2026-00296
    Event Type
    Malfunction
    Date Received
    March 6, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 23, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904490363
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B3. DATE OF EVENT: (B)(6) 2026. B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHILE USING THE PANEL PHOENIX PMIC-110 A PATIENT ISOLATE (ENTEROCOCCUS FAECALIS) HAD AN INTERMEDIATE MIC (FALSE RESISTANT) FOR THE DRUG DAPTOMYCIN. THE USER PERFORMED REPEAT TESTING. THE USER ALSO STATED THAT THEY DO NOT REPORT RESULTS THEY DO NOT TRUST TO PROVIDERS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K020322, K021954, K022172, K023273, K023301, K023568, K024152, K030091, K030677, K031306, K031679, K032131, K033784, K033889, K033907, K040006, K040106, K040716, K050089, K050555, K051689, K053241, K060214, K060217, K060218, K060493, K070809, K082538, K082852, K082913, K131331, AND K14046. H3. 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 WHILE USING THE PANEL PHOENIX PMIC-110 A PATIENT ISOLATE (ENTEROCOCCUS FAECALIS) HAD AN INTERMEDIATE MIC (FALSE RESISTANT) FOR THE DRUG DAPTOMYCIN. THE USER PERFORMED REPEAT TESTING. THE USER ALSO STATED THAT THEY DO NOT REPORT RESULTS THEY DO NOT TRUST TO PROVIDERS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE PANEL PHOENIX PMIC-110 THE USER NOTED AN INCREASED INCIDENCE OF INTERMEDIATE MICS FOR THE DRUG DAPTOMYCIN FOR ENTEROCOCCUS SPP. ISOLATES. THE USER PERFORMED REPEAT TESTING STATING THAT SOME OF THE TIME THE EXPECTED MIC IS OBTAINED. THE USER ALSO STATED THAT THEY DO NOT REPORT RESULTS THEY DO NOT TRUST TO PROVIDERS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598487 PANEL PHOENIX PMIC-110 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5301898 30382904490363

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown