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

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

A collaborative investigation was completed by data innovations (manufacturer), abbott laboratories (distributor), and west virginia university medical center (facility).Investigation with the facility determined that the troponin units should have been reported out as ng/l but instead were being reported to the laboratory information system (lis) as ng/ml.During a review of the laboratory instrument configuration, it was found that the incorrect unit value of ng/ml was configured, which resulted in laboratory results being sent with the incorrect units to the lis.The investigation found that the site had recently completed an upgrade project to move the facility from one instance of instrument manager (im) to another instance.The site indicated that during the upgrade process there was not adequate time to complete testing before going live.The investigation also determined that a rule (user facility programmed logic) was in place to set an error code indicating that units do not match.A separate rule to hold results used by the facility was not configured to include holding results when the units do not match.This is not a malfunction of the instrument manager medical device.This is the result of a configuration error.The facility indicated that 37 patients had troponin level reported at a level lower than actual by 1000x, of which four (4) patients with troponin elevation indicating cardiac injury (but reported as normal) were not properly diagnosed and treated, and eleven (11) patients with troponin elevation indicating possible cardiac injury (but reported as normal) will need further follow up to determine clinical impact.Additionally, eleven (11) patients with troponin elevation indicating cardiac injury (but reported as normal) were properly diagnosed and treated despite the incorrect reporting, and an additional eleven (11) patients had an incorrect reporting of troponin with no clinical impact.

Event Description

A representative from a reseller reported on 23 august 2023 that troponin results were sent to the laboratory information system (lis) with the incorrect units.The troponin units should have been reporting out as ng/l but instead were reported as ng/ml.This issue resulted in 37 patients having the troponin level reported at a level lower than actual by 1000x.

• 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: 17783046
• MDR Text Key: 323859413
• Report Number: 1225673-2023-00006
• 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: 09/20/2023

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
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/20/2023
• Patient Sequence Number: 1