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

Model Number V8.14.10

Device Problem Application Network Problem (2879)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The customer site ((b)(6) medical center) could not get instrument manager to start back up again.Investigation conducted by the distributor (b)(4) and data innovations' customer service department determined this was due to unanticipated updates and movement of server by the medical center's local it department.Also, the medical center removed the antivirus exceptions that must be in place per documentation for instrument manager to operate.This was not a malfunction of instrument manager, the user did not follow documented instructions.The medical center reported that they experienced delay in turn around times for key tests (based off visual inspection of graphs in lab intelligence) and wanted incident ticket marked as potentially reportable.The medical center is still pending a patient impact statement post investigation.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): DATA INNOVATIONS LLC; 120 kimball avenue; suite 100; south burlington VT 05403
• Manufacturer (Section G): DATA INNOVATIONS LLC; 120 kimball avenue; suite 100; south burlington VT 05403
• Manufacturer Contact: heather hogan ; 120 kimball avenue; suite 100; south burlington, VT 05403 ; 8022643410
• MDR Report Key: 8680492
• MDR Text Key: 205088821
• Report Number: 1225673-2019-00007
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 06/07/2019

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 Operator: Health Professional
• Device Model Number: V8.14.10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1