MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) NUC 4 OS IMG IOT10/EPI 4.0; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 444162

Device Problem False Positive Result (1227)

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

Event Date 03/21/2023

Event Type  malfunction  

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.The issue being reported is with the epicenter software which is loaded in the nuc please see below for epicenter software 510k information being used: d1: medical device brand name: bd epicenter¿ single user software.D2a: common device name: calculator/data processing module.D2b: medical device type or (procode):jqp.D4 medical device catalog #: 444165.G5.Pma/510k info: exempt.

Event Description

It was reported that bd epicenter¿ single user software upgrade was not blocked and synercid is not meant to provide result but it did.The following information was provided by the initial reporter: reported that after epi upgrade to v 7.21q synercid was not blocked/suppressed as the discontinuation customer letter stated and customer did it manually.1- d-test failed and transferred clinda as sensitive, gentamycin, moxifloxacin and tetracycline should¿ve not cross to lis.2-gentamycin and moxifloxacin should¿ve not cross to lis.

Manufacturer Narrative

H.6 investigation summary: customer reported that after epi upgrade to v 7.21q (444162/sn (b)(6) synercid was not blocked/suppressed as the discontinuation customer letter stated and customer did it manually.Upon further investigation, the panels used contained synercid and the results on those lots of panels should have been reported as expected.This is not a confirmed complaint of a bd product.Complaints for software were under statistical control for the month of march.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 Description

It was reported that bd epicenter¿ single user software upgrade was not blocked and synercid is not meant to provide result but it did.The following information was provided by the initial reporter: reported that after epi upgrade to v 7.21q synercid was not blocked/suppressed as the discontinuation customer letter stated and customer did it manually 1- d-test failed and transferred clinda as sensitive, gentamycin, moxifloxacin and tetracycline should¿ve not cross to lis.2-gentamycin and moxifloxacin should¿ve not cross to lis.

• Brand Name: NUC 4 OS IMG IOT10/EPI 4.0
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16773343
• MDR Text Key: 313634330
• Report Number: 1119779-2023-00448
• 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: 06/01/2023

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
• Device Operator: Other
• Device Catalogue Number: 444162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 06/01/2023
• Supplement Dates FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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