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

Model Number	441007
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd epicenter¿ single user software an application specimen management error was observed were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
Additional Manufacturer Narrative
It was determined in review of this record that the incorrect guideline was used to complete the decision tree for this product.A new not reportable decision tree has been completed using the epicenter guidelines instead.After review it was determined to be a communication error due to loss of connection to instruments.This mdr should be considered cancelled.
Event or Problem Description
It was reported that while using bd epicenter¿ single user software an application specimen management error was observed were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

• Brand Name: BD EPICENTER SINGLE USER SOFTWARE
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11586567
• Report Number: 1119779-2021-00580
• Device Sequence Number: 2955955
• Product Code: JQP
• UDI-Device Identifier: 00382904410070
• UDI-Public: 00382904410070
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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
• Operator of Device: Other
• Device Model Number: 441007
• Device Catalogue Number: 441007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2021
• Supplement Date Received by Manufacturer: 03/06/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1