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	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G5.Pma / 510(k)#: 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 while using the bd phoenix¿ automated microbiology system frequent misidentifications occurred with patient samples.The user noted two specific misidentifications, one isolate was identified as an e.Coli, and the other was identified as morganella morganii.The user used maldi to correctly identify the isolates.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: a discrepancy in identification results between phoenix 100 and maldi was reported.The customer advised that maldi had identified a sample as e.Coli, while phoenix 100 had produced a different result using panel nmic/id 402, and another sample was identified by maldi as morganella morgani, while phoenix 100 had identified this as leminorella grimontii using panel unmic/id 403.Bd applications communicated with the customer through remote assistance to confirm the correct workflow was performed for the panel procedure and the starter plates.No errors were reported with the instrument.An investigation into the associated reagents was opened.No service was performed upon the instrument and testing was repeated.As no failure of the instrument was identified, this is an unconfirmed failure of the phoenix 100.Further investigation will occur for the associated reagents.The root cause of the failure is not known.Device history record 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 against the instrument related to this failure mode.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.Bd quality will continue to closely monitor for trends associated with this complaint.
Event or Problem Description
It was reported while using the bd phoenix¿ automated microbiology system frequent misidentifications occurred with patient samples.The user noted two specific misidentifications, one isolate was identified as an e.Coli, and the other was identified as morganella morganii.The user used maldi to correctly identify the isolates.No health impact or consequence reported.

• 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: 19363497
• Report Number: 1119779-2024-00397
• Device Sequence Number: 3798502
• Product Code: LON
• UDI-Device Identifier: 00382904481001
• UDI-Public: (01)00382904481001
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: 04/30/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2014
• 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