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	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone # (b)(6).The information for the additional 510k is as follows: 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 during use of the bd phoenix¿ automated microbiology system there was false resistance in patient results.The results were verified by manual methodology.No health impact or consequence reported.
Event or Problem Description
It was reported during use of the bd phoenix¿ automated microbiology system there was false resistance in patient results.The results were verified by manual methodology.No health impact or consequence reported.
Additional Manufacturer Narrative
H.6 investigation summary : a results failure was reported on a phoenix 100 instrument.The customer reported a false resistance issue with the instrument.The field service engineer (fse) was dispatched for investigation.The fse verified that the tips used are not elongated, thus potentially causing contamination through the pipette that touches the tube at the time of transfer.The fse carried out the panel preparation process very carefully to avoid contamination and perform sanitization on the pipette.The fse has verified that the false resistance issue has not occurred.This is not true failure of bd instrument.The complaint is unconfirmed.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.No new risks or hazards, or changes to existing risks/hazards, were identified because of this complaint.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.

• 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: 18614551
• Report Number: 1119779-2024-00056
• Device Sequence Number: 7668406
• Product Code: LON
• UDI-Device Identifier: 00382904481001
• UDI-Public: (01)00382904481001
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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: 01/05/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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