MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM; SEE H.10

Model 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	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd phoenix¿ automated microbiology system has had several mis-id¿s.The following information was provided by the initial reporter: customer reported that they have had several mis-id¿s.They perform biofire on blood cultures, and the phoenix id¿s were different than maldi.One isolate was identified by maldi as e.Coli and phoenix called it k.Pneumoniae.Another was called proteus by maldi but providencia by phoenix.Customer did not have full details but will send in lab reports.Customer was also unaware to the incident start date, but said it was last week or the week before.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.D2a: common device name: system, test, automated antimicrobial susceptibility, short incubation.
Additional Manufacturer Narrative
H6.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 several gram negative mis-id's from blood cultures.The customer reported that one isolate was identified by maldi as e.Coli but the phoenix identified the isolate as k.Pneumoniae.Another isolate was identified by maldi as proteus but the phoenix identified the isolate as providencia.Lab reports or instrument log files were not provided.No instrument errors were noted.The root cause of the failures are unknown.This is an unconfirmed 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 of the one already described above.Complaints for results are within statistical control for the month of (b)(6) 2023.The upper control limit was not breached.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.
Event or Problem Description
It was reported that bd phoenix¿ automated microbiology system has had several mis-id¿s.The following information was provided by the initial reporter: customer reported that they have had several mis-id¿s.They perform biofire on blood cultures, and the phoenix id¿s were different than maldi.One isolate was identified by maldi as e.Coli and phoenix called it k.Pneumoniae.Another was called proteus by maldi but providencia by phoenix.Customer did not have full details but will send in lab reports.Customer was also unaware to the incident start date, but said it was last week or the week before.

• Brand Name: BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM
• Common Device Name: SEE H.10
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17002744
• Report Number: 1119779-2023-00598
• Device Sequence Number: 6343953
• Product Code: LON
• UDI-Device Identifier: 00382904481001
• UDI-Public: 00382904481001
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K020321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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 Model Number: 448100
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2016
• 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