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

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	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that while using bd phoenix¿ automated microbiology system, there was false resistance of one panel.There was no patient impact.The following information was provided by the initial reporter: "s.Aureus teicoplanin resistant on phoenix (mic=4).On further testing using e-test the mic was 1mg/l.Phoenix also called amc=r on a proteus mirabilis, which was fully sensitive on disc.Which panels were used? pmic lot: 2285329, nmic lot 2263172.What are the lot numbers for the kits used? ast indicator: lot 2298623 exp 21/10/23, id broth lot 2280803 exp 03/10/23, ast broth lot 2216995 26/07/23".
Additional Manufacturer Narrative
H.6 investigation summary a failure for false resistance was reported on a phoenix 100 instrument (p/n 48100, s/n (b)(6)).The customer reported that they had false resistance on two isolates.S.Aureus was teicoplanin resistant mic=4 on phoenix and mic=1 on e test.P.Mirabilis was amc resistant on phoenix and sensitive on disc diffusion.No instrument issues were reported therefore this is an unconfirmed failure of a bd product.The root cause is unknown at this time.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 for this instrument was reviewed and revealed no previous complaints related to this failure mode.Complaints for results are within statistical control for the month of june 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 while using bd phoenix¿ automated microbiology system, there was false resistance of one panel.There was no patient impact.The following information was provided by the initial reporter: "s.Aureus teicoplanin resistant on phoenix (mic=4).On further testing using e-test the mic was 1mg/l.Phoenix also called amc=r on a proteus mirabilis, which was fully sensitive on disc.Which panels were used? pmic lot: 2285329.Nmic lot 2263172.What are the lot numbers for the kits used? ast indicator: lot 2298623 exp 21/10/23.Id broth lot 2280803 exp 03/10/23.Ast broth lot 2216995 26/07/23".

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17255219
• Report Number: 1119779-2023-00733
• Device Sequence Number: 6058658
• Product Code: LON
• UDI-Device Identifier: 00382904481001
• UDI-Public: 00382904481001
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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: 06/15/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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