MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	448100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone #: (b)(6) g.5.Pma / 510(k)#: there were multiple 510k numbers reported to be involved: k020321, k020322, k020323, k040099, k131331 h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use with the bd phoenix¿ automated microbiology system, there were issues with identification of patient sample.There was no report of patient impact.
Event or Problem Description
It was reported that during use with the bd phoenix¿ automated microbiology system, there were issues with identification of patient sample.There was no report of patient impact.
Additional Manufacturer Narrative
H.6.Investigation summary: "a failure for mis-identification of results was reported on a phoenix 100 instrument (p/n 448100, s/n (b)(6)).A customer reported there is identification problem.Remote assistance provided to the customer."source adjustment", "uv adjustment" and "normalizer cvs" were carried out.Light source failure of rings a and b was found.The root cause is light source rings a and b failure.The user is informed and it is recommended for the moment to use only c and d rings.This is confirmed failure of a bd product.No samples were expected to be received as part of this complaint, and therefore no samples were returned and no returned material investigation could occur.Dhr review is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.Service history review was completed and revealed no further cases related to this failure mode, outside ot the one already described above.Quality will continue to monitor the results complaints for phoenix 100 instruments.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.".

• Brand Name: BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
• Common Device Name: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18383741
• Report Number: 1119779-2023-01417
• Device Sequence Number: 14154341
• Product Code: LON
• UDI-Device Identifier: 00382904481001
• UDI-Public: (01)00382904481001
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 448100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown