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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd epicenter¿ single user software amikacin susceptibility is being incorrectly interpreted.The following information was provided by the initial reproter: customer is reporting amikacin susceptiblity is being incorrectly interpreted by epicenter.It is falsely resulting susceptible on results that should be intermediate to patient charts, so this is very much impacting patient care.
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 amikacin susceptibility is being incorrectly interpreted.The following information was provided by the initial reporter: customer is reporting amikacin susceptibility is being incorrectly interpreted by epicenter.It is falsely resulting susceptible on results that should be intermediate to patient charts, so this is very much impacting patient care.
Additional Manufacturer Narrative
H.6.Investigation summary: customer is reporting amikacin susceptibility is being incorrectly interpreted by epicenter.Field apps advised customer to check/change amikacin breakpoints in epicenter and to manually change breakpoints and self-validate the new breakpoints.Customer stated they will use the previous year clsi/fda breakpoints.Field apps provided support and resolved the issue.The field apps who provided the customer with support to resolve their issue stated, "epicenter is calling amikacin correctly; the lis was interpreting the results since epicenter is only sending over the mic and the lis is applying the interps." this is not a confirmed complaint of a bd product.Complaints for software were under statistical control for the month of july.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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17455491
• Report Number: 1119779-2023-00835
• Device Sequence Number: 2712398
• Product Code: JQP
• UDI-Device Identifier: 00382904410070
• UDI-Public: 00382904410070
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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: 07/20/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• 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