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

Model Number 8.13.00

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2022

Event Type  malfunction  

Event Description

A laboratory user reported on (b)(6) 2022 that results for troponin t were erroneously auto-filed to the patient chart due to there being no hemolysis (hil) results.Troponin t is falsely depressed by hemolysis, so a falsely low troponin t could be released in error.The technician observed the hemolysis index was too high for troponin when reviewing other chemistry results on the same patient.There was no patient harm as the incorrect results were removed from the patient chart and the floor/rn was notified of the error.The patient was redrawn and no harm or medical decision was made based on the erroneous result.Initial data received from the customer for use in the investigation has not been able to identify a root cause, and therefore it is not yet determined whether or not this was a malfunction of the instrument manager software.The investigation is ongoing at the time of this report.

Manufacturer Narrative

A collaborative investigation is being completed by data innovations (manufacturer) and (b)(6) health system corporation - (b)(6) (customer) and is in progress at the time of this report.On (b)(6) 2022, data innovations was notified of an incident related to our product, instrument manager.The incident was that results for troponin t were erroneously auto-filed to the patient chart due to there being no hemolysis (hil) results.Troponin t is falsely depressed by hemolysis, so a falsely low troponin t could be released in error.The technician observed the hemolysis index was too high for troponin when reviewing other chemistry results on the same patient.There was no patient harm as the incorrect results were removed from the patient chart and the floor/rn was notified of the error.The patient was redrawn and no harm or medical decision was made based on the erroneous result.The customer has provided data for use in the investigation, however it is insufficient to determine the root cause and therefore, the investigation has not yet determined if this is malfunction of the instrument manager software and is ongoing at the time of this report.As additional information is received to complete the investigation and make a final determination, an update to this report will be filed at that time.

• 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: 14503883
• MDR Text Key: 300564988
• Report Number: 1225673-2022-00004
• 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: 05/25/2022

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: 8.13.00
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1