MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD EPICENTER¿ SINGLE USER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 444165

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd epicenter¿ single user software, the false positive results were received.Staph saprophyticus alerted the clinician as mrsa.There was not report of confirmatory testing or patient impact.The following information was provided by the initial reporter.The customer stated: customer reported that staph saprophyticus alerted the clinician as mrsa.

Event Description

It was reported when using the bd epicenter¿ single user software, the false positive results were received.Staph saprophyticus alerted the clinician as mrsa.There was not report of confirmatory testing or patient impact.The following information was provided by the initial reporter.The customer stated: customer reported that staph saprophyticus alerted the clinician as mrsa.

Manufacturer Narrative

H.6 investigation summary: bd service remoted in (444165/ and observed custom rule sn (b)(6)).After consult internally, the following info was provided - bd service walked the customer through adding the organism name and advised to consult with the clinician for other types of s.Aureus to be added.Please note that this rule did not get reported through lis, it only alerted the lab clinician.No patient management was affected.Issue resolved.This is not a confirmed complaint of a bd product.Complaints for software were under statistical control for the month of june.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
• Type of Device: 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: 14973730
• MDR Text Key: 304511214
• Report Number: 1119779-2022-00978
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 444165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 07/10/2022
• Supplement Dates Manufacturer Received: 12/29/2022
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other