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	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address:(b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd phoenix¿ automated microbiology system instrument has identification failures.The following information was provided by the initial reporter: customer informs that equipment has identification and antibiogram failures aborting panels.
Additional Manufacturer Narrative
H.6 investigation summary: a results failure was reported on a phoenix m50 instrument (p/n 448100, (b)(6) ).The customer reported that the instrument had identification and antibiogram failures aborting panels.A bd field service engineer (fse) was dispatched to investigate.The fse reviewed the instrument and proceeded to do a corrective maintenance, the fse checked the log and the power supply voltages, an adjustment was performed to the source, to the normalize cv, to the filter panel and to the uv, after the corrective maintenance was completed, the equipment performed as expected.The root cause for this failure mode is not known.This is a confirmed failure of a bd product.Samples were not received by quality for investigation and thus, returned material investigation could not occur.If samples are received at a later date, the complaint may be reopened.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 for this instrument was reviewed and revealed no previous complaints related to this failure mode.The only case associated with this instrument was the successful install.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.H3 other text : see h.10.
Event or Problem Description
It was reported that bd phoenix¿ automated microbiology system instrument has identification failures.The following information was provided by the initial reporter: customer informs that equipment has identification and antibiogram failures aborting panels.

• 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: 16537422
• Report Number: 1119779-2023-00268
• Device Sequence Number: 17723466
• Product Code: LON
• UDI-Device Identifier: 00382904481001
• UDI-Public: 00382904481001
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2023

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: 02/16/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2014
• 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