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

Model Number 8.15.01

Device Problem Installation-Related Problem (2965)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

A representative from the distributor reported on (b)(6) 2022 that an architect instrument exception for a fentanyl test triggered a rule in instrument manager due to an "else" statement without results.The result should have been reviewed and rerun, but was instead released to the laboratory information system by a technician in the laboratory.The original, incorrect result, was reported to the patient's chart as negative.Upon review and rerun, the fentanyl result was positive.A corrective report had to be made to the patient's chart.There was no documentation that this corrective report had been called to the patient's provider.The patient was discharged from the emergency department shortly after all results were posted to the chart.

Manufacturer Narrative

A collaborative investigation was completed by data innovations (manufacturer), abbott laboratories (distributor) and beaumont hospital dearborn (facility).Investigation with the facility determined that a rule (user facility programmed logic) was triggered due to an "else" statement configured without results.The fentanyl test result that was negative was then released to the laboratory information system by the technician instead of rerunning the sample and posted to the patient chart.Upon review of the result, the test was rerun and the fentanyl result was positive.This caused a corrective report to be made to the patient's chart.There was no documentation that this corrective report had been called to the patient's provider.The patient was discharged from the emergency department shortly after the results were posted to the patient's chart.The investigation could not determine with certainty that the discrepant results did not cause patient harm or affect the patient's treatment.The facility indicated that the patient has not had any subsequent patient admissions or appointments following the incident.Additionally, due to limited information available, the investigation could not determine if the provider was made aware of the corrected report before the patient was discharged or if the negative result led to the patient discharge.The root cause determined that the rule should not have fired but was triggered by the instrument exception workflow.The workflow with the instrument exception is for the technologist to review and reject the exception instead of releasing the result to the laboratory information system.Because of this, the distributor worked with the facility to write a new set of rules for negative and cutoff values for this test.While this is not a malfunction of the instrument manager medical device (rules were working as programmed), it is being reported due to the facility's inability to provide a patient impact of the user error.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINCIAL 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: 15391348
• MDR Text Key: 305153223
• Report Number: 1225673-2022-00008
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2022

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: 8.15.01
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1