MAUDE Adverse Event Report: DATA INNOVATIONS LLC INSTRUMENT MANAGER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number 8.17.10

Device Problem Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2022

Event Type  malfunction  

Event Description

A representative from the distributor reported on (b)(6) 2022 that the free thyroxine index (fti) calculation is producing incorrect results and that the fti results are not crossing from instrument manager (im) to the laboratory information system (lis).

Manufacturer Narrative

A collaborative investigation was completed by data innovations (manufacturer), abbott laboratories (distributor), and bay care health system (facility).Investigation with the facility determined that the free thyroxine index (fti) calculation was producing incorrect results and the results were not crossing from instrument manager (im) to the laboratory information system (lis).During review of the rule (user facility programmed logic) that calculates fti, it was determined that the specimen id value that was set for specimen user field (suf) 09 was pulling the wrong value for suf09 which caused the incorrect results to be calculated.The distributor worked with the facility to fix the rule to pull the correct value for suf09 and the fix has been confirmed to have resolved the issue.This is not a malfunction of instrument manager medical device.This incident is due to the misconfiguration of the specimen user field within the rule that was created by abbott laboratories.The facility indicated 35 incorrect results were sent to the lis which have since been corrected.It is unknown at this time if there was any patient harm due to the incorrect results.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): DATA INNOVATIONS LLC; 463 mountain view drive; colchester VT 05446
• Manufacturer Contact: sara shaw ; 463 mountain view drive; colchester, VT 05446 ; 8026582850
• MDR Report Key: 15830958
• MDR Text Key: 307319171
• Report Number: 1225673-2022-00016
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2022

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
• Device Model Number: 8.17.10
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/19/2022
• Patient Sequence Number: 1