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

Device Problem Data Problem (3196)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

A collaborative investigation is being completed by data innovations (manufacturer) and commonspirit health (user facility) and is in progress at the time of this report.On (b)(6)2023, data innovations was notified of an issue related to our product, instrument manager.The user facility indicated that when groups/screen on one specimen and a group on a different specimen for the same patient are ordered, one of the blood groups is being canceled before it reaches the immulink laboratory instrument.This type of blood grouping is required for transplant patients.Insufficient information is available to complete the investigation.The investigation is pending specimen event log and communication trace data being provided from the facility to be analyzed.Data innovations has not received a response regarding patient harm.As additional information is received to complete the investigation, an update to this report will be filed at that time.

Event Description

A representative from a user facility reported on (b)(6) 2023 that blood group orders are being cancelled on patients with multiple specimens.

Event Description

A representative from a user facility reported on 05 october 2023 that blood group orders are being cancelled on patients with multiple specimens.

Manufacturer Narrative

Additional information: a representative from the user facility provided data to be reviewed and additional information on the potential patient impact.A review of the specimen event log (sel) provided determined that the blood group was being cancelled in the laboratory's laboratory information system (lis) safetrace and the cancellation was then passed through instrument manager (im) to the immulink laboratory instrument.This is not a malfunction of instrument manager software device based on the cancellation taking place outside of im.The user facility stated that there was no patient harm as a result of one of the blood groups being cancelled in the lis.Based on the additional data received by the user facility, four values have been updated in section h6.First, health effect - clinical code has been updated to 4582: no clinical signs, symptoms, or conditions.Second, the health effect - impact code has been updated to 2199: no health consequences or impact.Third, investigation findings has been updated to 213: no device problem found.Fourth, investigation conclusions has been updated to 4310: cause traced to non-device related factors.Information from original report: a collaborative investigation is being completed by data innovations (manufacturer) and common spirit health (user facility) and is in progress at the time of this report.On 5 october 2023, data innovations was notified of an issue related to our product, instrument manager.The user facility indicated that when groups/screen on one specimen and a group on a different specimen for the same patient are ordered, one of the blood groups is being canceled before it reaches the immulink laboratory instrument.This type of blood grouping is required for transplant patients.Insufficient information is available to complete the investigation.The investigation is pending specimen event log and communication trace data being provided from the facility to be analyzed.Data innovations has not received a response regarding patient harm.As additional information is received to complete the investigation, 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; suite 305; colchester VT 05446
• Manufacturer Contact: sara shaw ; 463 mountain view drive; suite 305; colchester, VT 05446 ; 8026582850
• MDR Report Key: 18068120
• MDR Text Key: 327320338
• Report Number: 1225673-2023-00008
• 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
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 12/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1