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 09/15/2023

Event Type  malfunction  

Event Description

It was reported that during use with the bd epicenter¿ single user software, patient results were misassociated.There was no report of patient impact.The following information was provided by the initial reporter, translated from italian: problem associating access number (b)(6) with the right registry.Epicenter continues to show a patient from 2022 with the accession number mentioned above.

Manufacturer Narrative

H3.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 during use with the bd epicenter¿ single user software, patient results were misassociated.There was no report of patient impact.The following information was provided by the initial reporter, translated from italian: problem associating access number (b)(4) with the right registry.Epicenter continues to show a patient from 2022 with the accession number mentioned above.

Manufacturer Narrative

H.6.Investigation summary: customer reporting a problem associating access number (b)(4) with the right registry.Epicenter (444165/(b)(6)) continues to show a patient from 2022 with the accession number mentioned above.Discovered that there was an unfinalized test that caused the association issue.This is not a confirmed complaint of a bd product.Complaints for software were under statistical control for the month of september.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.H3 other text : see h.10.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17917007
• MDR Text Key: 325585386
• Report Number: 1119779-2023-01096
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 00382904410070
• UDI-Public: 00382904410070
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• 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: 10/24/2023

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: 09/15/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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