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 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

E.6 initial reporter e-mail: (b)(6).E.7 initial reporter addr 1: (b)(6).H.3.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¿ pid that there was misidentification.The following information was provided by the initial reporter: the percentage of misidentification is increasing with this batch.It is mainly strains of staphylococcus aureus that are identified as another staphylococcal species or the opposite.Did the failure occur with control or patient samples? patients sample and controls.What confirmatory tests were performed to determine that the results were in error? yes because the identification results were not consistent with the appearance of the colonies on the cultures and pre-diagnostic tests.Were any wrong results reported to the doctors? no.

Event Description

It was reported that while using the bd phoenix¿ pid that there was misidentification.The following information was provided by the initial reporter: the percentage of misidentification is increasing with this batch.It is mainly strains of staphylococcus aureus that are identified as another staphylococcal species or the opposite.Did the failure occur with control or patient samples? patients sample and controls what confirmatory tests were performed to determine that the results were in error? yes because the identification results were not consistent with the appearance of the colonies on the cultures and pre-diagnostic tests.Were any wrong results reported to the doctors? no.

Manufacturer Narrative

H.6 investigation summary: this complaint is not confirmed.This complaint is for misidentification of staphylococcus aureus as staphylococcus warneri when using phoenix panel pid (448008) batch number 2152720.The customer did not provide panel returns or isolate returns but provided lab reports for the investigation.The lab reports show an organism identified as s.Warneri when using the complaint batch.To investigate, three (3) retention panels from complaint batch 2152720 were tested using qc isolates of s.Aureus a29213 on a phoenix m50 instrument and evaluated for identification results.Additionally, three (3) retention panels from complaint batch 2152720 were tested using qc isolates of s.Aureus a43300 on a phoenix m50 instrument and evaluated for identification results.All six (6) panels identified 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 no additional complaints on this complaint batch.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.Please continue to communicate any additional concerns.Bd encourages you to consider the following parameters to optimize results within your laboratory.Qc testing should only be performed on 2nd pass subcultures and avoid using colonies that have been sub-cultured multiple times.Isolated colonies are to be used for inoculation and carefully check purity plates to ensure the inoculum consisted of one isolate type.Optimum performance comes from using fresh 18-24 hour, well-isolated colonies.Ensure proper, sufficient inoculum density.Allow bubbles to dissipate after vortexing.Properly calibrate the bd phoenixspec¿ nephelometer with in-date mcfarland calibration standards.Use swabs with minimal fiber shed.Make the proper inoculum density for the inoculum system setting (i.E., if preparing a 0.25 mcfarland inoculum, ensure that the system is set to 0.5 inoculum mode).Volume of id broth should be visually assessed for any obvious low fills ensure proper incubation temperature and environment.Use the correct media type as listed as acceptable for use in the user¿s manual (note - it is helpful to disclose the media type and vendor when providing the details of the complaint).Handle panels by only touching the sides; touching the front or back of the panels may cause interference in the readings and lead to errors follow user¿s manual instructions for time limits on pouring inoculated id broth into the panel and placing the panel into the instrument; extended periods of time outside of the stated limitations may yield errors.

• 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: 16939061
• MDR Text Key: 315303265
• Report Number: 1119779-2023-00558
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 30382904480081
• UDI-Public: 30382904480081
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 448008
• Device Catalogue Number: 448008
• Device Lot Number: 2152720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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