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	08/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported by the customer that they had problems finalizing a panel on bd epicenter¿ single user software.The following information was provided by the customer: "problems finalizing a panel (it is finalized but epicenter does not allow flagging to save).Urgent application support request sent to specialists.".
Event or Problem Description
It was reported by the customer that they had problems finalizing a panel on bd epicenter¿ single user software.The following information was provided by the customer: "problems finalizing a panel (it is finalized but epicenter does not allow flagging to save).Urgent application support request sent to specialists.".
Additional Manufacturer Narrative
H.6 investigation summary: bd quality has reviewed the complaint, service investigation and adverse event questions.The results of this investigation have not identified any new hazards, new risks, or specific trends.No further investigation is required at this time.Quality will continue to trend the reported issue.Further investigation will be required if an actionable level is reached.H3 other text : see h.10.
Event or Problem Description
It was reported by the customer that they had problems finalizing a panel on bd epicenter¿ single user software.The following information was provided by the customer: "problems finalizing a panel (it is finalized but epicenter does not allow flagging to save).Urgent application support request sent to specialists.".
Additional Manufacturer Narrative
H.6 investigation summary: customer reporting that they are having problems finalizing a panel (it is finalized but epicenter (444165/ sn (b)(6) does not allow flagging to save).The customer associated the panel with an incorrect blood culture test.Working with the customer, made the change of association so that the panel was associated with the right sample, resolved a present attention issue and the sample was finalized correctly.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.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15396909
• Report Number: 1119779-2022-01176
• Device Sequence Number: 17439101
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2023

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 Model Number: 441007
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 09/21/2022; 03/24/2023
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 09/29/2022; 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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