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

Model Number V8.15.10

Device Problem Application Program Version or Upgrade Problem (2881)

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

Event Date 06/11/2019

Event Type  malfunction  

Event Description

Data innovations' (di) customer (b)(6) hospital and clinics inc updated an instrument (myla) in the lab late in the day (b)(6) 2019.The following morning after that upgrade, instrument manager was no longer sending results to the laboratory information system (lis).In troubleshooting the issue with shands, di's support department discovered the driver for the myla (b)(4) has some configuration properties set to null which was causing the results to not pass through the systems correctly.Data innovations has not been able to recreate the issue, nor determine how the fields became null.It is not possible for an end user to change the fields to null, and di has been unable to determine how this occurred, and has not been able to reproduce it.Di has not been able to confirm this is an instrument manager malfunction.There was no patient harm as a result of this issue, there was a delay in reporting results to the lis.Di is reporting this event since a root cause has not been determined and it has not been established if this was or was not an instrument manager malfunction.

• 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: 8768807
• MDR Text Key: 209405914
• Report Number: 1225673-2019-00008
• 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: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 07/08/2019

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: V8.15.10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2017
• 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