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

Model Number 441007

Device Problem False Negative Result (1225)

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

Event Date 03/16/2023

Event Type  malfunction  

Event Description

It was reported that bd epicenter¿ single user software antibiotics are not being reported.The following information was provided by the initial reporter: customer reported acinetobacter that was ran on instrument 1 and meropenem was not done by phoenix.We need to check again why instrument 1 is not doing the meropenem but it¿s done on instrument 2.

Manufacturer Narrative

(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

H.6 investigation summary: reported acinetobacter that was ran on instrument 1 and meropenem was not done by phoenix.We need to check again why instrument 1 is not doing the meropenem but it¿s done on instrument 2.Customer followed up by phone and asked to check the mic availability on instrument 1 and noted it was not possibly saved during the last phone call.Walked the customer through how to save and noted the mic availability was checked even after exiting and rechecked again.This is not a confirmed complaint of a bd product.Complaints for software were under statistical control for the month of march.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 bd epicenter¿ single user software antibiotics are not being reported.The following information was provided by the initial reporter: customer reported acinetobacter that was ran on instrument 1 and meropenem was not done by phoenix.We need to check again why instrument 1 is not doing the meropenem but it¿s done on instrument 2.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16729096
• MDR Text Key: 313400304
• Report Number: 1119779-2023-00416
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 00382904410070
• UDI-Public: 00382904410070
• 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: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 441007
• Device Catalogue Number: 444165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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