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	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that bd epicenter¿ single user software patient results were impacted by incorrect results for tetracycline resistance.Customer did not provide information on treatment change to patient or amount of samples affected.The following information was provided by the initial reporter: customer responded that all tetracycline results where the rule was fired between (b)(6) 2022 and (b)(6) 2022 impacted patient results.Tetracycline for esbl isolates was changed to resistant as a result of rule 1487 for patients from (b)(6) 2022 to (b)(6) 2022.
Additional Manufacturer Narrative
H.6 investigation summary customer is reporting xpert rule 1487 was fired for tetracycline and minocycline which changes from susceptible to resistant.Bdxpert rule 1487 was created and released in pud v6.71 for customers who wished to suppress cefepime, along with the other cephalosporins when esbl was detected by the phoenix panel, even though the cefepime breakpoints within the pud were aligned with the current clsi breakpoints.Rule 1487 was configured to be default disabled on install and the customer could choose to manually enable the rule, if they wished to use it.Bdxpert rule 1487 was obsoleted in pud v7.01 because it was determined that it was no longer needed per clsi/eucast documentation.At the time of pud v7.01 release, the bdxpert team was not aware that the rule logic was incorrectly inclusive of tetracyclines.This is a confirmed complaint of a bd product.Complaints for results were under statistical control for the month of october.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 bd epicenter¿ single user software patient results were impacted by incorrect results for tetracycline resistance.Customer did not provide information on treatment change to patient or amount of samples affected.The following information was provided by the initial reporter: customer responded that all tetracycline results where the rule was fired between (b)(6) 2022 and (b)(6) 2022 impacted patient results.Tetracycline for esbl isolates was changed to resistant as a result of rule 1487 for patients from (b)(6) 2022.

• 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 ; 8448235433
• MDR Report Key: 16475779
• Report Number: 1119779-2023-00168
• Device Sequence Number: 18004213
• Product Code: JQP
• UDI-Device Identifier: 00382904410070
• UDI-Public: 00382904410070
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/11/2023

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: 02/20/2023
• Supplement Date Received by Manufacturer: 03/11/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• 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