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

Model Number 8.16.20

Device Problem Installation-Related Problem (2965)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2022

Event Type  malfunction  

Manufacturer Narrative

Upon investigation with the facility, it was determined that when the driver configuration option "by test code sub id" is enabled on the epic driver and the "suppress unsolicited results for ordered samples" configuration option is also enabled, the driver intentionally uses the "by test code sub id" so that all tests are built into the result message that is sent to the laboratory information system (lis).After reviewing the driver configuration options that were enabled at the facility, only the "suppress unsolicited results for ordered samples" was enabled, not the "by test code sub id" option.Because hemolysis test results are associated with a test code sub id, the hemolysis results were not being included in the first message being sent to the lis.This is not a malfunction of instrument manager medical device.This incident is due to the misconfiguration of the epic driver within the driver settings by the facility.A patient impact statement has not yet been received by data innovations and therefore patient impact has been unable to be determined.The investigation is ongoing at the time of this report.

Event Description

A facility reported on 9 september 2022 that when multiple test panels are run on the same specimen, and the sample is hemolyzed, the hemolysis result was not being received in the first message that is sent from instrument manager medical device to epic.This causes results to auto verify in epic without the hemolysis value which may result in certain analytes being reported when they should not be when there is high hemolysis.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, PRODUCT CODE
• 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: 15552619
• MDR Text Key: 306692516
• Report Number: 1225673-2022-00011
• 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: 10/06/2022

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: 8.16.20
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1