MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number 443624

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2024

Event Type  malfunction  

Event Description

Report 2 of 2.It was reported that during use with the bd phoenix¿ m50 automated microbiology system, 2 samples of e.Coli were incorrectly identified as cisterbacteria.There was no report of patient impact.

Manufacturer Narrative

B3.Date of event is unknown.The date received by manufacturer has been used for this field.H6.Investigation summary: a results failure was reported on a phoenix m50 instrument.The customer reported discrepant results on their instrument and requested a health check be performed.A field service engineer (fse) arrived onsite to troubleshoot the instrument.The fse performed a full preventative maintenance (pm) and health check of the instrument.The pm reviewed the hardware of the system, internal and external lights and alerts, internal temperature, carousel rotation speed, door alignment and power supply voltages.A ccd alignment and adjustment was performed as well as a cv test and filter panel test.All testing passed and the instrument was found to be functioning as expected.The instrument was returned to the customer in working order.The root cause of the failure is not known.This is an unconfirmed failure of a 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 for this instrument was reviewed and revealed no previous complaints related to this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.

• Brand Name: BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM
• Type of Device: 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: 18960585
• MDR Text Key: 338614540
• Report Number: 1119779-2024-00218
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 00382904436247
• UDI-Public: (01)00382904436247
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 443624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1