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

Model Number 8.17.20.07

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2023

Event Type  malfunction  

Event Description

A laboratory user reported on (b)(6) 2023 that the facility's instrument manager server was losing connection and the subsequent failover resulted in short periods of inaccessibility.

Manufacturer Narrative

Upon investigation, it was determined that the configuration in place at the site for system processes associated with the server infrastructure caused the instrument manager (im) servers to lose connection and fail over.The facility has snapshot processes enabled on the infrastructure which, based on the timing of the snapshot processes, were in conflict with the timing of the im system processes that resulted in a network interruption and im failing over to a backup system.Within technical documentation, data innovations recommends not performing snapshots on the im server as this can cause unnecessary failover to occur.A patient impact statement has not yet been received by data innovations and therefore patient impact has been unable to be determined.The investigation is ongoing at the time of this report.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CACLULATOR/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 dr; colchester, VT 05446 ; 8026582850
• MDR Report Key: 17760998
• MDR Text Key: 324008825
• Report Number: 1225673-2023-00005
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8.17.20.07
• Date Manufacturer Received: 08/17/2023
• Patient Sequence Number: 1