BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PMIC110

    MDR report key: 12662125 · Received October 19, 2021

    Report

    Report Number
    1119779-2021-01682
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    September 22, 2021
    Report Date
    November 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR LOW MIC WITH OXACILLIN WHEN USING PHOENIX PANEL PMIC-110 (449036) BATCHES 1103261 AND 1196728. THE CUSTOMER DID NOT PROVIDE ISOLATES OR PANEL RETURNS OR LAB REPORTS FOR INVESTIGATION. THE COMPLAINT BATCHES WERE NOT AVAILABLE FOR INVESTIGATION DUE TO THE BATCHES BEING EXPIRED AT THE TIME OF THE INVESTIGATION. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON EITHER OF THE COMPLAINT BATCHES. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 1103261. A REVIEW OF COMPLAINTS REVEALED SIX (6) ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 1196728; NONE OF THE 6 OTHER COMPLAINTS WERE CONFIRMED. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BASED ON THE INVESTIGATION PERFORMED, THIS COMPLAINT IS UNABLE TO BE CONFIRMED. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. PER BALTRMPHXIDASTAPH REV 10 VERSION H, ID 1.0-1.15, INDICATES THE POTENTIAL RISK OF A FALSE SUSCEPTIBLE RESULT WAS ASSESSED AS S4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX PMIC110 ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALL ACTIVITY COMMENT: CUSTOMER PROBLEM: CUSTOMER IS REPORTING THAT THEIR PMIC-110 PANELS ARE UNDERCALLING THE OXACILLIN RESULT WHEN COMPARED TO OTHER TEST METHODS."

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1103261, MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, DEVICE MANUFACTURE DATE: 2021-04-13, MEDICAL DEVICE LOT #: 1196728, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2021-07-15. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE BD PHOENIX PMIC110 IS AN ANTIMICROBIAL RESISTANCE PANEL CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K040106, K033889, K060218, K021954, K140468, K050555, K082913, K051689, K033784, K060218, K082538, K082852, K053241, K023273, K031679, K020322, K040006, K023568, K070809, K031306, K060217, K030091, K023301, K040716, K024152, K050089, K031679, K033907, K060218, K022172, K032131, K060214, K142170, K030677, K131331, K060493.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD PHOENIX PMIC110 ATYPICAL GROWTH WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CALL ACTIVITY COMMENT: CUSTOMER PROBLEM: CUSTOMER IS REPORTING THAT THEIR PMIC-110 PANELS ARE UNDERCALLING THE OXACILLIN RESULT WHEN COMPARED TO OTHER TEST METHODS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559026 BD PHOENIX PMIC110 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown