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	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with the bd phoenix¿ automated microbiology system, the instrument failed to correctly identify organisms.There was no report of patient impact.
Additional Manufacturer Narrative
E1.Initial reporter address: (b)(6).G5.Multiple 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.
Additional Manufacturer Narrative
H.6.Investigation summary: a failure for misidentification of results was reported on a phoenix 100 instrument (p/n 448100, s/n (b)(6).The customer reported that there were failures in the identification of microorganisms.The fse was dispatched for this case.Based on the work order summary, the fse proposed the equipment pre-installations must first be ensured before moving the equipment in the same counter near the bactec fx, place a film on half of the windows to prevent sun entry and install air conditioning.There is an electrical outlet in the laboratory with a neutral - ground voltage of 1.23 vac, phase - neutral 124.3 vac and phase - ground 125.1 vac and it is requested to verify the panel of that outlet in order to be able to draw a derivation for the equipment.Therefore, this is not confirmed failure of 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.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.
Event or Problem Description
It was reported that during use with the bd phoenix¿ automated microbiology system, the instrument failed to correctly identify organisms.There was no report of patient impact.

• 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: 18746799
• Report Number: 1119779-2024-00128
• Device Sequence Number: 15020501
• Product Code: LON
• UDI-Device Identifier: 00382904481001
• UDI-Public: (01)00382904481001
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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): 05/02/2024

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: 01/23/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 05/21/2024
• 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