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

Model Number 8.17.10.06

Device Problem Installation-Related Problem (2965)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2022

Event Type  malfunction  

Event Description

A representative from the distributor reported on (b)(6) 2022 that amphetamine values were resulting as positive on instruments and are crossing as negative into the laboratory information system (lis).The facility had a rule (user facility programmed logic) in place to determine positive and negative cutoff values where every value less than 1000 ng/ml was to be interpreted as negative and any value greater than 1000 ng/ml to be interpreted as positive.The facility identified the issue on 4 september 2022 and had to correct numerous results.

Manufacturer Narrative

A collaborative investigation was completed by data innovations (manufacturer), (b)(4) (distributor) and (b)(6) health system (facility).Investigation with the facility determined that upon reviewing the assay package insert, the cutoff value in the configuration should be 500 ng/ml, not 1000 ng/ml.Because of this incorrect configuration value, results that were actually negative based on the 500 ng/ml value were being resulted as positive.This is not a malfunction of instrument manager medical device based on the incorrect value being configured in a rule at the facility.The facility is actively working on an investigation into identifying any potential patient impact.While this is not a malfunction of instrument manager medical device (rules were working as programmed), it is being reported due a patient impact statement not yet received by the facility due to the ongoing patient impact investigation.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, PRODUCT CODE
• Manufacturer (Section D): DATA INNOVATIONS LLC; 463 mountan view drive; colchester VT 05446
• Manufacturer Contact: sara shaw ; 463 mountain view drive; colchester, VT 05446 ; 8026582850
• MDR Report Key: 15546912
• MDR Text Key: 306614122
• Report Number: 1225673-2022-00010
• 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: 10/05/2022

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: 8.17.10.06
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1