BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ YEAST ID

    MDR report key: 15645677 · Received October 21, 2022

    Report

    Report Number
    1119779-2022-01319
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    October 10, 2022
    Report Date
    December 15, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JXB
    UDI-DI
    30382904483167
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2022-01319 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THERE WAS AN INCREASE IN ABORTED PANELS WITH MESSAGE ¿ONE OR MORE FLUORESCENT WELLS ARE OUT OF RANGE¿. THE ID PORTION OF THE PANEL HAS BEEN COMPLETED AND THE ISOLATE SHOULD BE RETESTED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTINUED AND INCREASING EVIDENCE OF PHOENIX YEAST PANELS ABORTED BY SPECIAL MESSAGE ¿ONE OR MORE FLUORESCENT WELLS ARE OUT OF RANGE¿ THE ID PORTION OF THE PANEL HAS BEEN COMPLETED AND THE ISOLATE SHOULD BE RETESTED. LOT 2060322 EXPIRATION DATE: 2023-03-31.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THERE WAS AN INCREASE IN ABORTED PANELS WITH MESSAGE ¿ONE OR MORE FLUORESCENT WELLS ARE OUT OF RANGE¿. THE ID PORTION OF THE PANEL HAS BEEN COMPLETED AND THE ISOLATE SHOULD BE RETESTED. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTINUED AND INCREASING EVIDENCE OF PHOENIX YEAST PANELS ABORTED BY SPECIAL MESSAGE ¿ONE OR MORE FLUORESCENT WELLS ARE OUT OF RANGE¿ THE ID PORTION OF THE PANEL HAS BEEN COMPLETED AND THE ISOLATE SHOULD BE RETESTED. LOT 2060322. EXPIRATION DATE: 2023-03-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928557 BD PHOENIX¿ YEAST ID KIT, IDENTIFICATION, YEAST JXB BECTON, DICKINSON & CO. (SPARKS) 448316 2060322 30382904483167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown