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

Model Number 8.16.00.20

Device Problem Patient Data Problem (3197)

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

Event Date 12/04/2020

Event Type  malfunction  

Event Description

A laboratory user reported on (b)(6) 2020 that their data innovations instrument manager software was responding very slowly in processing lab results from one site to the laboratory information system.The user reported that the slowness was delaying reporting of lab results to ordering providers.There was no report of patient harm.It has not yet been determined if this is a malfunction of the software or a configuration error by the user.Data innovations technical support and the customer were unable to determine the cause of the poor performance at the time of this report.The investigation is ongoing.There was no report of patient harm on first report but data innovations did not receive a response from the customer whether the customer investigation identified any other impact from the delay.

• Brand Name: INSTRUMENT MANAGER
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): DATA INNOVATIONS LLC; 120 kimball ave; suite 100; south burlington VT 05403
• Manufacturer Contact: matthew smith ; 120 kimball ave; suite 100; south burlington, VT 05403 ; 8026582850
• MDR Report Key: 11100529
• MDR Text Key: 224547716
• Report Number: 1225673-2020-00005
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2020

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: 8.16.00.20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1