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

Model Number V8.14.10

Device Problem Date/Time-Related Software Problem (2582)

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

Event Type  malfunction  

Event Description

Patient date of birth (dob) changed (b)(6).Due to the erroneous dob, logic in the instrument where the data was being transmitted stopped processing, preventing the orders from being processed via the instrument manager workflow.The site had to manually enter the order in the instrument.At this time, troubleshooting is continuing to determine the root cause of this issue.There has been no report of patient harm due to this issue.

Event Description

Patient date of birth (dob) changed from 19xx to 20xx.Due to the erroneous dob, logic in the instrument where the data was being transmitted stopped processing, preventing the orders from being processed via the instrument manager workflow.The site had to manually enter the order in the instrument.At this time, troubleshooting is continuing to determine the root cause of this issue.There has been no report of patient harm due to this issue.

Manufacturer Narrative

This issue was reported by a distributor, who's customer is using instrument manager in (b)(6).After the distributor was able to go to the customer site to look at the configuration of instrument manager and their regional settings, it was determined the customer was using a 2 digit year in parts of their software setup.Instrument manager is designed to be configured using a 4 digit year to prevent this type of issue.This was a user error where the customer did not configure the instrument manager system as recommended (using a 4 digit year).No patients were harmed due to this issue.

• 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
• MDR Report Key: 8185676
• MDR Text Key: 131341474
• Report Number: 1225673-2018-00015
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

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: 11/21/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 11/21/2018
• Supplement Dates FDA Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1