BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ SMIC/ID-101

    MDR report key: 19646755 · Received July 1, 2024

    Report

    Report Number
    1119779-2024-00531
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 16, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904488025
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN LOT NUMBER: D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G5. PMA / 510(K)#: K050745, K050747, K050780, K050865, K050881, K050946, K050982, K051109, K051138, K051204, K051266, K051272, K051692, K062206. 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

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF STREPTOCOCCUS PNEUMONIAE AS STREPTOCOCCUS MITIS WHEN USING PHOENIX PANEL SMIC/ID-101 (CATALOG NUMBER 448802) BATCH NUMBER UNKNOWN. THE CUSTOMER DID NOT PROVIDE PHOENIX GENERATED LAB REPORTS, ISOLATES OR PANEL RETURNS FOR THE INVESTIGATION. THE BATCH NUMBER WAS NOT PROVIDED, THEREFORE THIS COMPLAINT IS UNCONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS COULD NOT BE PERFORMED SINCE A BATCH NUMBER WAS NOT PROVIDED. A REVIEW OF COMPLAINTS COULD NOT BE PERFORMED SINCE A BATCH NUMBER WAS NOT PROVIDED. COMPLAINT TRENDING WAS PERFORMED AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD 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 WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE (STREP PNEUMONIA) WAS MISIDENTIFIED AS STREP MITIS OR AS AN UNIDENTIFIED ORGANISM. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ SMIC/ID-101 A PATIENT ISOLATE (STREP PNEUMONIA) WAS MISIDENTIFIED AS STREP MITIS OR AS AN UNIDENTIFIED ORGANISM. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181813 BD PHOENIX¿ SMIC/ID-101 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) UNKNOWN 30382904488025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown