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

Catalog Number	444165
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	08/02/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that while using bd epicenter¿ single user software, there is a misassociation of data linked to one specimen.No patient impact reported.The following information was provided by the initial reporter: "the doctor reports an anomaly whereby, for example, if a bottle is positive, it is discharged as positive by the instrument - and epicenter also reports it as positive.But then as soon as other vials linked to the same access number/patient are finalized, epicenter reports all the vials, including the one previously discharged and positive, as negative.".
Additional Manufacturer Narrative
H3.Investigation summary: the doctor reports an anomaly whereby, for example, if a bottle is positive, it is discharged as positive by the instrument - and epicenter also reports it as positive.But then as soon as other vials linked to the same access number/patient are finalized, epicenter reports all the vials, including the one previously discharged and positive, as negative.Upon investigation, it was determined that the collection date was greater than the test start date.A change was made at the lis to address the issue.This is not a confirmed complaint of a bd product.Complaints for software were under statistical control for the month of august.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 or Problem Description
It was reported that while using bd epicenter¿ single user software, there is a misassociation of data linked to one specimen.No patient impact reported.The following information was provided by the initial reporter: "the doctor reports an anomaly whereby, for example, if a bottle is positive, it is discharged as positive by the instrument - and epicenter also reports it as positive.But then as soon as other vials linked to the same access number/patient are finalized, epicenter reports all the vials, including the one previously discharged and positive, as negative.".

• 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
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17558837
• Report Number: 1119779-2023-00898
• Device Sequence Number: 14713738
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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
• Operator of Device: Other
• Device Catalogue Number: 444165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown