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	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6); initial reporter address: (b)(6).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 a misassociation was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: " client reports that they register a type of sample, but when the result will be released, the type of sample was changed to blood.".
Event or Problem Description
It was reported that while using bd epicenter¿ single user software a disassociation was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "client reports that they register a type of sample, but when the result will be released, the type of sample was changed to blood".
Additional Manufacturer Narrative
H.6.Investigation: client reports that they register a type of sample, but when the result will be released, the type of sample was changed to blood.During investigation of this issue, it appears that this change is occurring within the customer lis system and not epicenter.This is not a confirmed complaint of a bd product.

• 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: 11753744
• Report Number: 1119779-2021-00745
• Device Sequence Number: 4167875
• Product Code: JQP
• UDI-Device Identifier: 00382904410070
• UDI-Public: 00382904410070
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/23/2021

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: 04/08/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1