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

Model Number 8.17.10

Device Problem Installation-Related Problem (2965)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2023

Event Type  malfunction  

Event Description

A representative from the distributor reported on 13 april 2023 that a urine calculation rule (user facility programmed logic) for microalbumin/- creatinine is not calculating correctly.

Manufacturer Narrative

A representative from the distributor reported on 13 april 2023 that a urine calculation rule (user facility programmed logic) for microalbumin/- creatinine is not calculating correctly.A collaborative investigation was completed by data innovations (manufacturer), abbott laboratories (distributor), and (b)(6)(facility).Investigation with the facility determined that if the test for serum creatinine is not collected the same day as urine test for microalbumin, the serum calculation can be pulled from a previous result available within the last 7 days.A representative from the facility identified the issue when a calculation for the creatinine clearance did not calculate correctly or at all.This was a result of the serum result coming after the urine result.The workflow for this type of test is normally the serum test is run first with a urine test run within a day or two later.Investigation determined that because the serum result came after the urine result, which is not typical, this caused one of the rules (user programmed logic) to not fire correctly.A review of the workflow determined that the rules did not consider patients who may have multiple urine tests within the previous 7 days.A review of the rule determined that the rule was referencing a date field for the urine creatinine test that was still blank, and that the distributor worked with the facility to correct the rule to consider the collection date/time for both the creatinine serum and creatinine urine and to use the difference to trigger if the calculation should be run or not.The facility indicated 7 incorrect results were sent to the lis and patient chart which have since been corrected.This is not a malfunction of the instrument manager medical device because the rules were working as configured.It is unknown at this time if there was any patient harm due to the incorrect results therefore the issue is being reported.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATION/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 ; 8882991750
• MDR Report Key: 16924325
• MDR Text Key: 315417760
• Report Number: 1225673-2023-00003
• 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: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2023

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: 8.17.10
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1