MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ PID; GRAM POSITIVE IDENTIFICATION PANEL

Model Number 448008

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

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

It was reported that bd phoenix¿ pid patient samples were misidentified for staphylococcus epidermidis.No injuries were reported.The following information was provided by the initial reporter: staphylococcus aureus was identified as staphylococcus epidermidis.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd phoenix¿ pid patient samples were misidentified for staphylococcus epidermidis.No injuries were reported.The following information was provided by the initial reporter: staphylococcus aureus was identified as staphylococcus epidermidis.

Manufacturer Narrative

This complaint is not confirmed.This complaint is for misidentification with s.Aureus as s.Epidermidis when using phoenix panel pid (448008) batch number 2074215.The customer did not provide panel returns, isolate returns or lab reports for the investigation.To investigate, three (3) retention panels from complaint batch 2074215 were tested using qc isolates of s.Aureus a29213, and another three (3) from the same batch were inoculated with in house isolate s.Aureus a43300 on a phoenix m50 instrument and evaluated for identification results.In addition, one (1) retention panel from the same material but different batch were tested using qc isolates of s.Aureus a29213 and another one (1) from the same batch were inoculated with in house isolate s.Aureus a43300 on a phoenix m50 instrument and evaluated for identification results.All eight (8) panels identified correctly as s.Aureus, therefore, this complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed one (1) additional complaint on the complaint batch, related to this defect.Complaint trending was performed, and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.H3 other text : see h.10.

• Brand Name: BD PHOENIX¿ PID
• Type of Device: GRAM POSITIVE IDENTIFICATION PANEL
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16482894
• MDR Text Key: 310966988
• Report Number: 1119779-2023-00226
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 30382904480081
• UDI-Public: 30382904480081
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 448008
• Device Catalogue Number: 448008
• Device Lot Number: 2074215
• 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: 03/15/2022
• 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