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

Catalog Number 448008

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

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

Event Date 03/18/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 while using bd phoenix¿ pid, s.Aureus.Was misidentified as s.Warneri.No patient impact reported.The following information was provided by the initial reporter: "the customer redid the test run and the m50 returned 96% s.Warneri, even though the isolate was s.Aureus.".

Event Description

It was reported that while using bd phoenix¿ pid, s.Aureus.Was misidentified as s.Warneri.No patient impact reported.The following information was provided by the initial reporter: "the customer redid the test run and the m50 returned 96% s.Warneri, even though the isolate was s.Aureus.".

Manufacturer Narrative

H.6.Investigation summary: this complaint is for misidentification and no-id of staphylococcus aureus when using phoenix panel pid (b) batch number 2116435.The customer did not provide isolates, panels or phoenix generated lab reports for investigation.To investigate, one retention sample from the complaint batch was inoculated with qc isolate streptococcus aureus a43300 and placed in a phoenix m50 for identification results.Next, one retention sample from the complaint batch was inoculated with qc isolate streptococcus aureus a29213 and placed in a phoenix m50 for identification results.Last, one retention sample from the complaint batch was inoculated with qc isolate streptococcus aureus 4757 and placed in a phoenix m50 for identification results.All three panels identified the isolate as s.Aureus, this complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.Complaint trending was performed and no trends were identified associated with this defect.A review of complaints revealed two other complaints on this batch, none of which are 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.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17389729
• MDR Text Key: 319705243
• Report Number: 1119779-2023-00801
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 448008
• Device Lot Number: 2116435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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