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	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that user error on the bd epicenter¿ single user software caused the resistance bp for imipenem on enterococci to be set at 4 instead of 8.There was no report of patient impact.The following information was provided by the initial reporter: "customer has noticed that the bp for pud v6.81 has bp for imipenem on enterococcus spp.Is set at 4 instead of 8.Eucast 2020 sets r>4 and on epicenter should be >/=8.Pud v6.81 has resistance bp for imipenem on enterococci at 4 instead of 8.Incident happened during use".
Event or Problem Description
It was reported that user error on the bd epicenter¿ single user software caused the resistance bp for imipenem on enterococci to be set at 4 instead of 8.There was no report of patient impact.The following information was provided by the initial reporter: "customer has noticed that the bp for pud v6.81 has bp for imipenem on enterococcus spp.Is set at 4 instead of 8.Eucast 2020 sets r>4 and on epicenter should be >/=8.Pud v6.81 has resistance bp for imipenem on enterococci at 4 instead of 8.Incident happened during use".
Additional Manufacturer Narrative
H.6 investigation summary customer has noticed that the bp for pud v6.81 has bp for imipenem on enterococcus spp.Is set at 4 instead of 8 on epicenter (material 441007/sn (b)(6).).This issue is being addressed under (b)(4).In an upcoming version of the pud do to be released this quarter.This is a confirmed complaint of a bd product.Per baltrm-441007-aph revision 5, the failure associated to this complaint is a user inconvenience which is a severity of s1; reference id 6.6.Complaints for software were under statistical control for the month of november.No trends indicated.Dhr review is not required for stand alone 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: 12965073
• Report Number: 1119779-2021-01928
• Device Sequence Number: 4416385
• Product Code: JQP
• UDI-Device Identifier: 00382904410070
• UDI-Public: 00382904410070
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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: 441007
• 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: 11/11/2021
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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