MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD EPICENTER¿ SINGLE USER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 444165

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

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

Event Date 10/13/2023

Event Type  malfunction  

Event Description

It was reported that while using bd epicenter¿ single user software, there was 1 incorrect patient.This is a report of one occurrence, no report of adverse or injury.The following information was provided by the initial reporter: it was reported by the customer that epicenter was the incorrect patient.Troubleshooting steps performed by service: new bottle attached to old patient.Logged in via bomgar.Moved new vial to a dummy accession number, finalized old specimen, created new specimen and then moved bottle to correct accession.Reviewed/answered adverse event questions, including patient impact with the customer (if applicable) (y/n): n/a.No impact on patient results.On (b)(6) 2023 - patient fields updated: hazard, injury or erroneous results? no.Hazard, injury or erroneous results details incorrect patient.

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.

Manufacturer Narrative

H.6.Investigation summary: customer indicating that a sample is connected to the wrong patient ((b)(6)).Troubleshooting indicated that the new bottle attached to old patient.Logged in via bomgar.Moved new vial to a dummy accession number, finalized old specimen, created new specimen and then moved bottle to correct accession.It is expected that customers finalize older specimen to avoid this possibility in the future.This is not a confirmed complaint of a bd product.Complaints for software were under statistical control for the month of october.No trends indicated.Device history record review is not required for standalone software.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

It was reported that while using bd epicenter¿ single user software, there was 1 incorrect patient.This is a report of one occurrence, no report of adverse or injury.The following information was provided by the initial reporter: it was reported by the customer that epicenter incorrect patient.Troubleshooting steps performed by service: new bottle attached to old patient.Logged in via bomgar.Moved new vial to a dummy accession number, finalized old specimen, created new specimen and then moved bottle to correct accession.Reviewed/answered adverse event questions, including patient impact with the customer (if applicable) (y/n): n/a.No impact on patient results.On fri oct 13 18:31:07 utc 2023 - patient fields updated: hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.Incorrect patient.

• Brand Name: BD EPICENTER¿ SINGLE USER SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18059410
• MDR Text Key: 327623692
• Report Number: 1119779-2023-01198
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 444165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• 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