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

Model Number 443624

Device Problem Incorrect Measurement (1383)

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

Event Date 04/04/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: pma / 510(k)#: k020321 and k040099.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 while using bd phoenix¿ m50 automated microbiology system there was a misidentification of organism.There was no report of patient impact.The following information was provided by the initial reporter: misidentification of organism.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1119779-2021-00701 was sent in error.This complaint is not mdr reportable.This product is not sold within the us and bd does not sell a similar product within the us.

Event Description

It was reported while using bd phoenix¿ m50 automated microbiology system there was a misidentification of organism.There was no report of patient impact.The following information was provided by the initial reporter: misidentification of organism.

• Brand Name: BD PHOENIX M50 AUTOMATED MICROBIOLOGY SYSTEM
• Type of Device: SYSTEM, TEST, AUTO, ANTIMICRO SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11717449
• MDR Text Key: 277999347
• Report Number: 1119779-2021-00701
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 00382904436247
• UDI-Public: 00382904436247
• Combination Product (y/n): N
• PMA/PMN Number: K131331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• 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
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1