MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE; CALCULATION/DATA PROCESSING MODULE, FOR CLINICAL USE, PRODUCT CODE: JQP

Model Number 8.15.11

Device Problem Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 12/28/2022

Event Type  malfunction  

Event Description

A facility reported on (b)(6) 2022, that a new troponin assay, hstni_stat, does not post the results as expected when sent from the data management system (dms).

Manufacturer Narrative

A facility reported on (b)(6) 2022, that a new troponin assay, hstni_stat, does not post results as expected when sent from data management system (dms).A rerun of results are seen in the dms results trace log but are not viewable in instrument manager (im).If results are resent from the dms, then the results are seen in im.It was later reported by the site, on (b)(6) 2023, that this issue had also been occurring with human chorionic gonadotropin (hcg) tests.Upon investigation it was found that the hgc and hstni_stat assays were included in a "hold results until complete" function group on the dms instrument driver.With the "hold results until complete" function disabled the issue cannot be reproduced.Further investigation found temporary (imtemp) entries for the held tests.The imtemp entries were found to be missing a timeout configuration value for the test.A root cause analysis revealed that a text box in the driver configuration properties contains leading spaces that are hidden and unexpected.The driver is not configured to handle the leading spaces and therefore the results are not released as expected.This constitutes a malfunction of a component driver (dms driver v8.00.0008) associated with the data innovations (di) im medical device.A known issue (ki) has been created to further investigate and correct this issue.A patient impact statement has not yet been received by data innovations and therefore, patient impact has been unable to be determined.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATION/DATA PROCESSING MODULE, FOR CLINICAL USE, PRODUCT CODE: JQP
• Manufacturer (Section D): DATA INNOVATIONS LLC; 463 mountain view drive; colchester VT 05446
• Manufacturer Contact: sara shaw ; 463 mountain view drive; colchester, VT 05446 ; 8026582782
• MDR Report Key: 16821513
• MDR Text Key: 314087216
• Report Number: 1225673-2023-00002
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2023

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 Model Number: 8.15.11
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1