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 01/15/2024

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

Report 2 of 2: it was reported that during use of the bd phoenix¿ m50 automated microbiology system, there was a mis-identification of a patient sample as enterobacter cloacae and citrobacter farmeri using unmic/id-409.Maldibiotyper gave result of e.Coli.There was no report of patient impact.

Manufacturer Narrative

H.6.Investigation summary: "a results failure was reported on a phoenix m50 instrument.The customer reported erroneous identification of gram negative organisms.The customer reported that the instrument identified a k.Pnuemoniea as lelliottia amnigena biogroup 2 and an e.Coli was incorrectly identified as an e.Cloacae and c.Farmerii.Instrument log files were collected and reviewed by the global expert.The root cause of this failure is not known.This is a confirmed failure of a bd product.No physical samples were received as part of this complaint; however, instrument log files were provided and reviewed, confirming the issue.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 case #'s (b)(4) related to this failure mode.Complaints for results are within statistical control for the month of january 2024.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.".

Event Description

Report 2 of 2: it was reported that during use of the bd phoenix¿ m50 automated microbiology system, there was a mis-identification of a patient sample as enterobacter cloacae and citrobacter farmeri using unmic/id-409.Maldibiotyper gave result of e.Coli.There was no report of patient impact.

• 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: 18759671
• MDR Text Key: 336977961
• Report Number: 1119779-2024-00132
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K131331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2017
• 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