MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM; SEE H.10

Model Number 443624

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

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

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

Common device name: system, test, automated antimicrobial susceptibility, short incubation 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 while using the bd phoenix¿ m50 automated microbiology system that there was misidentification.The following information was provided by the initial reporter: the application specialist requires instrumental verification associated with his support for identification problem investigations.

Manufacturer Narrative

"a failure for mis-identification of results was reported on a phoenix m50 instrument (p/n 443624, s/n (b)(6) ).An application specialist requested verification of the m50 instrument while troubleshooting a mis-identification issue.The field service engineer (fse) arrived onsite to troubleshoot the instrument.The fse performed an instrument check, completed general cleaning of the instrument and cleaning of the optics.Colormetric calibration and verification was completed.The fse also replaced normalizers and lightsource and the expiration date was approaching.The instrument was found to operating as expected and preventative measures only were carried out.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, outside ot the one already described above.Complaints for results are within statistical control for the month of january 2023.The upper control limit was not breached.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.H3 other text : see h.10.

Event Description

It was reported that while using the bd phoenix¿ m50 automated microbiology system that there was misidentification.The following information was provided by the initial reporter: the application specialist requires instrumental verification associated with his support for identification problem investigations.

• Brand Name: BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM
• Type of Device: SEE H.10
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16374985
• MDR Text Key: 309599517
• Report Number: 1119779-2023-00130
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 00382904436247
• UDI-Public: 00382904436247
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 443624
• Device Catalogue Number: 443624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2018
• 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