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

Model Number 8.16.10

Device Problems Installation-Related Problem (2965); Insufficient Information (3190)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

A laboratory user reported on 11 december 2023 that incoming result rules are firing on "send to host" action.When manually sending results to host (a feature within specimen manager workspace to send results to the laboratory information system (lis)) from a specimen manager workspace in instrument manager, rules in specific locations within the configuration in instrument manager for the instrument are firing when the laboratory would not expect them to fire.Preliminary investigation determined that the user facility has rules in place that will remove comments associated with the laboratory test and that the issue is limited to only when resending results to host.The user facility identified and reviewed all impacted rules and concluded there was no patient harm.Investigation to determine if this is a malfunction of instrument manager is ongoing at the time of this report.

Event Description

A laboratory user reported on 11 december 2023 that incoming result rules are firing on 'send to host' action.

Event Description

A laboratory user reported on 11 december 2023 that incoming result rules are firing on 'send to host' action.

Manufacturer Narrative

Additional information: after additional investigation, data innovations determined this was not a malfunction of instrument manager software.Review of data provided by the user facility determined that the customer configured rules that alter laboratory results were being configured in specific locations within instrument manager that, when using the send to host functionality within specimen management workspace, will fire a second time.Review of the send to host functionality determined that it is performing based on the design specifications and the intended use and therefore, is not a malfunction of instrument manager software.An update to the user documentation is planned to provide additional information when using specific rule types with the send to host functionality.Based on the determination, 3 values have been updated in section h6.First, medical device problem code has been updated to 2965: installation-related problem: problem associated with unsatisfactory installation, configuration, and/or setup of a specific device.Second, the investigation findings has been updated to 213: no device problem found.Third, the investigation conclusions has been updated to 61: cause traced to user > unintended use error caused or contributed to event.Information from original report: a laboratory user reported on 11 december 2023 that incoming result rules are firing on "send to host" action.When manually sending results to host (a feature within specimen management workspace to send results to the laboratory information system (lis)) from a specimen management workspace in instrument manager, rules in specific locations within the configuration in instrument manager for the instrument are firing when the laboratory would not expect them to fire.Preliminary investigation determined that the user facility has rules in place that will remove comments associated with the laboratory test and that the issue is limited to only when resending results to host.The user facility identified and reviewed all impacted rules and concluded there was no patient harm.Investigation to determine if this is a malfunction of instrument manager is ongoing at the time of this report.

• 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: 18490043
• MDR Text Key: 333020263
• Report Number: 1225673-2024-00001
• 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: 04/05/2024

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: 8.16.10
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 04/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1