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 09/16/2023

Event Type  malfunction  

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, a patient result was misassociated.The following information was provided by the initial reporter: customer complaints their patient mrn in epicenter is belongs to different patient via their lis.

Manufacturer Narrative

H3.Investigation summary: customer complains their patient mrn in epicenter (444165/jrpn20100762) belongs to different patient via their lis.The customer initially needed assistance disassociating an accession number.Upon call return, the customer stated that the issue had already been resolved.The customer was not able to provide any additional details for this case.This is not a confirmed complaint of a bd product.Complaints for misassociation 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 h10.

Event Description

It was reported that during use with the bd epicenter¿ single user software, a patient result was mis-associated.The following information was provided by the initial reporter: customer complaints their patient mrn in epicenter is belongs to different patient via their lis.

• 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: 17935947
• MDR Text Key: 325843131
• Report Number: 1119779-2023-01124
• 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: NA
• 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: 10/23/2023

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: 09/16/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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