BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL PMIC-110

    MDR report key: 18116376 · Received November 10, 2023

    Report

    Report Number
    1119779-2023-01214
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    September 27, 2023
    Report Date
    February 16, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G5. 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 H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR A PERFORMANCE ISSUE DUE TO NO MIC RESULTS WHEN USING PHOENIX PANEL PMIC-110 (CATALOG NUMBER 449036) BATCH NUMBER 3206534. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS, ISOLATES OR PHOENIX GENERATED LAB REPORTS BUT PROVIDED BINARY FILES FOR THE INVESTIGATION. THE CUSTOMER NOTED THAT COAGULASE NEGATIVE STAPHYLOCOCCUS IS FAILING ON PMIC PANELS. TO INVESTIGATE, THREE RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE STAPHYLOCOCCUS SCIURI A29062 AND PLACED IN A PHOENIX M50 FOR MIC RESULTS. RESULTS OF THE INVESTIGATION SHOW ALL PANELS RETURNED VALID MIC RESULTS. THIS COMPLAINT IS NOT CONFIRMED. THE BATCH HISTORY RECORDS WERE SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    REPORT 3 OF 3 IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX PANEL PMIC-110, COAG NEGATIVE STAPH FROM PATIENT SAMPLES FAILED ON PMIC PANELS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS HAVING X'S FOR ALL MICS WITH COAGULASE NEGATIVE STAPH CUSTOMER IS UNSURE OF ANY TREATMENT CHANGE, BUT THERE WAS DELAY OF AST RESULTS BY 48-72 HOURS DUE TO PERFORMING MANUAL SUSCEPTIBILITIES SINCE THE PMIC PANELS WERE NOT PROVIDING MICS REAGENTS AND PANELS STORED AT ROOM TEMP INDICATOR IS REFRIGERATED PANEL LOT #S: 3213270, 3206619, 3206534 ID BROTH LOT #: 3227240 AST BROTH LOT #: 3032736 4.5 ML AST BROTH LOT #: 3221350 AST INDICATOR LOT #: 3145101 NEW BOTTLE OF INDICATOR IS OPENED EVERY DAY PHOENIX AP SNS: # (B)(6). M50S SNS: # (B)(6). M50 SOFTWARE: 2.75.0.0, PUD: V7.21A, EPICENTER SOFTWARE: 7.52B".

    Description of Event or Problem · 0

    REPORT 3 OF 3 IT WAS REPORTED THAT DURING USE WITH THE BD PHOENIX PANEL PMIC-110, COAG NEGATIVE STAPH FROM PATIENT SAMPLES FAILED ON PMIC PANELS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS HAVING X'S FOR ALL MICS WITH COAGULASE NEGATIVE STAPH CUSTOMER IS UNSURE OF ANY TREATMENT CHANGE, BUT THERE WAS DELAY OF AST RESULTS BY 48-72 HOURS DUE TO PERFORMING MANUAL SUSCEPTIBILITIES SINCE THE PMIC PANELS WERE NOT PROVIDING MICS REAGENTS AND PANELS STORED AT ROOM TEMP INDICATOR IS REFRIGERATED PANEL LOT #S: 3213270, 3206619, 3206534 ID BROTH LOT #: 3227240 AST BROTH LOT #: 3032736 4.5 ML AST BROTH LOT #: 3221350 AST INDICATOR LOT #: 3145101 NEW BOTTLE OF INDICATOR IS OPENED EVERY DAY PHOENIX AP SNS: #1 (B)(4) M50S SNS: #1 (B)(4) M50 SOFTWARE: 2.75.0.0 PUD: V7.21A EPICENTER SOFTWARE: 7.52B."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193603 BD PHOENIX PANEL PMIC-110 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3206534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown