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 07/21/2023

Event Type  malfunction  

Event Description

Report 1 of 2.It was reported that while using bd phoenix¿ pid, customer states bacillus cereus being misidentified as step b.This is a report of two occurrence, no report of adverse or injury.The following information was provided by the initial reporter: it was reported by the customer that bacillus cereus being misidentified as step b on (b)(6) 2021 and (b)(6) 2022.Total quantity of product showing defect: 2 panels.Was this issue involving patient or non-patient samples (qc, validation testing or proficiency samples)?: patient.Hazard, injury or erroneous results?: yes.Hazard, injury or erroneous results details did a death occur?: tbd.Did an injury occur?: tbd.Did erroneous results occur?: yes.If yes¿detailed erroneous results (include # of errors and type): 2 mis-ids.

Manufacturer Narrative

E1: initial reporter phone #: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following information has been updated with corrected and/or additional information: d.4.Medical device lot #: 3018389.D.4.Medical device expiration date: 2024-01-15.H.4.Device manufacture date: 2023-01-18.Investigation summary: this complaint is for misidentification of bacillus cereus as streptococcus group b when using phoenix panel pid (catalog number 448008) batch numbers 3018389 and 3136815.The customer did not return panels or isolates but provided phoenix generated lab reports for the investigation.The lab reports show patient samples identified as streptococcus agalactiae with the complaint batches.To investigate, three retention panels each from complaint batches 3018389 and 3136815 were tested using in house isolate b.Cereus 1631 on a phoenix m50 machine and evaluated for identification results.All six panels identified their isolate as b.Cereus; therefore, this complaint is not confirmed for misidentification.The batch history record was satisfactory, and no quality notifications were generated during manufacturing and inspection.A review of complaints revealed three additional complaints on complaint batch 3018389, two of which are related to this defect and unconfirmed.A review of complaints revealed two additional complaints on complaint batch 3136815, one of which is related to this defect and unconfirmed.Complaint trending was performed, and no trends were identified associated with this defect.Bd will continue to monitor for trends and take action as necessary.

Event Description

Report 1 of 2.It was reported that while using bd phoenix¿ pid, customer states bacillus cereus being misidentified as step b.This is a report of two occurrence, no report of adverse or injury.The following information was provided by the initial reporter: it was reported by the customer that bacillus cereus being misidentified as step b on 7/21 and 8/22.Total quantity of product showing defect: 2 panels.Was this issue involving patient or non-patient samples (qc, validation testing or proficiency samples)? patient.Hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details did a death occur? tbd.Did an injury occur? tbd.Did erroneous results occur? yes.If yes, detailed erroneous results (include # of errors and type): 2 mis-ids.

• 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 ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18014630
• MDR Text Key: 326925695
• Report Number: 1119779-2023-01181
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 30382904480081
• UDI-Public: (01)30382904480081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/15/2024
• Device Catalogue Number: 448008
• Device Lot Number: 3018389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1