MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) NUC 4 OS IMG IOT10/EPI 4.0

Catalog Number 444165

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/18/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter email: (b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd epicenter¿ single user software are seeing association error's on vial with redundant sequence number's.The following information was provided by the initial reporter: have duplicate sequence numbers on the vials between 2019 and 2022.No impact on the patient file because the 2019 files are validated and finalized, but at the level of epicenter it does not match the number of the last patient.We noticed this through positive files that were not published.

Manufacturer Narrative

H.6 investigation summary: data shows that there are tests that are still pending and are never fed into the instrument.The vials are therefore always pending and when a sequence number associated with one of these old files is scanned, it is found associated with the old file and not with the new one.The help file contains information about pruning the database and is enabled by default.In addition, communication regarding database pruning occurs at the time of installation to ensure that the customer is aware of the impact of leaving old data in the system.In this case, it appears that the old data was never purged as recommended.This caused the data to be unintentionally mis-associated to an old file.This issue was discovered and corrected before any results were sent for the patient or to a prescriber.Therefore, configured epicenter (444165/sn (b)(6)) purge to purge pending tests older than 60 days and also purge samples with no tests or isolates.This is not a confirmed complaint of a bd product.Complaints for software were under statistical control for the month of december.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.H3 other text : see h.10.

Event Description

It was reported that bd epicenter¿ single user software are seeing association error's on vial with redundant sequence number's.The following information was provided by the initial reporter: have duplicate sequence numbers on the vials between 2019 and 2022.No impact on the patient file because the 2019 files are validated and finalized, but at the level of epicenter it does not match the number of the last patient.We noticed this through positive files that were not published.

• Brand Name: NUC 4 OS IMG IOT10/EPI 4.0
• Type of Device: NA
• 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: 16074996
• MDR Text Key: 306835874
• Report Number: 1119779-2022-01555
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

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: 444165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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