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	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd epicenter¿ single user software, misassociated data of one sample.No patient impact reported.The following information was provided by the initial reporter: "error 21220: the same organism id for isolate number 3 assigned to sample x collected on (b)(6) 2023 was isolated from the same patient on (b)(6) 2023 for sample y.The test has already been reported.".
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.
Additional Manufacturer Narrative
H.6.Investigation summary: customer reporting error 21220 (444165/ (b)(6)): the same organism id for isolate number 3 assigned to sample x collected on (b)(6) 2023 10was isolated from the same patient on (b)(6) 2023 for sample y.The problem was resolved independently by the customer by correcting the association.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, misassociated data of one sample.No patient impact reported.The following information was provided by the initial reporter: "error 21220: the same organism id for isolate number 3 assigned to sample x collected on (b)(6) 2023 was isolated from the same patient on (b)(6) 2023 for sample y.The test has already been reported.".

• 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: 17597672
• Report Number: 1119779-2023-00920
• Device Sequence Number: 7552245
• 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): 10/16/2023

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: 08/07/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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