BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC-306

    MDR report key: 12169861 · Received July 14, 2021

    Report

    Report Number
    1119779-2021-01170
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    May 1, 2021
    Report Date
    May 12, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS COMPLAINT IS FOR FALSE RESISTANCE OF CARBAPENEMS WHEN USING PHOENIX PANEL NMIC-306 (449292) BATCH NUMBER UNKNOWN. THE CUSTOMER DID NOT RETURN ISOLATES, PANELS, OR LAB REPORTS FOR INVESTIGATION. TO INVESTIGATE, FOUR RETENTION PANELS OF THE SAME CATALOG NUMBER WERE TESTED USING QC ISOLATES OF ESCHERICHIA COLI (A25922) AND KLEBSIELLA PNEUMONIAE (ENF14780) ON A PHOENIX INSTRUMENT AND EVALUATED FOR MIC RESULTS OF ERTAPENEM (ETP) AND MEROPENEM (MEM). TWO PANELS WERE TESTED PER ISOLATE. DURING INVESTIGATION, ALL PANELS YIELDED SATISFACTORY MIC RESULTS FOR BOTH ERTAPENEM (ETP) AND MEROPENEM (MEM). THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATION COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. A REVIEW OF COMPLAINTS COULD NOT BE COMPLETED AS THE BATCH NUMBER IS UNKNOWN. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC-306 FALSE RESISTANCE WAS OBSERVED BY THE LABORATORY PERSONNEL. AN E-TEST WAS USED TO CONFIRM THE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. "IT WAS REPORTED THAT CARBAPENEM RESISTANCE BUT E-TEST RESULTS IN CARBAPENEM SUSCEPTIBLE.".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE PANEL PHOENIX NMIC-306 IS AN ANTIMICROBIAL RESISTANCE PANEL CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K061327, K031912, K023444, K063824, K033560, K063573, K041384, K060217, K052269 , K181665 , K181665 , K181665, K181665 , K181665, K181665, K181665, K181665, K181665, K190905, K032655, K062944, K060444, K173252, K033362, K062207, K063811, K163637, K151320, K063301, K031530, K060447, K032567, K060257, K023634, K020322, K132674, K173523, K063486, K022129, K023858, K071623, K031699, K060447, K024153, K060214, K132909, K042932.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC-306 FALSE RESISTANCE WAS OBSERVED BY THE LABORATORY PERSONNEL. AN E-TEST WAS USED TO CONFIRM THE RESULTS. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. "IT WAS REPORTED THAT CARBAPENEM RESISTANCE BUT E-TEST RESULTS IN CARBAPENEM SUSCEPTIBLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064526 PANEL PHOENIX NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown