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 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use with the bd phoenix¿ m50 automated microbiology system, false vancomycin resistant results were obtained.There was no report of patient impact.Report 9 of 10.

Event Description

It was reported that during use with the bd phoenix¿ m50 automated microbiology system, false vancomycin resistant results were obtained.There was no report of patient impact.Report 9 of 10.

Manufacturer Narrative

H6.Investigation summary: a results failure was reported on a phoenix m50 instrument.The customer reported false vancomycin resistant results on 10 different patients for organisms like enterococcus sp.And staph sp.A field application specialist (fas) assisted the customer with troubleshooting the issue.It was confirmed that all qc organisms passed testing, the database was reviewed and found to be accurate and customer workflow was observed.The m50 instrument was found to be functioning as expected.The fas determined that the issue was caused during the pre-analytical phase of panel set up.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.Complaints for results did breach an alert level trend in the month of july 2023.An investigation into this breach did not reveal a trend with customer, root cause or failure mode.Quality will continue to monitor the results complaints for phoenix m50 instruments.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: 18496001
• MDR Text Key: 332983930
• Report Number: 1119779-2024-00020
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 00382904436247
• UDI-Public: (01)00382904436247
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K131331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• 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: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2018
• 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