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

Model Number V8.14.10

Device Problem Loss of Data (2903)

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

Event Type  Injury  

Event Description

The customer had an incorrectly written rule (configuration) which was changing a result of >5000 to <10.The rule did not contain an "is numeric" operator, so when a result is received with the ">", it causes the rule to fail.This is not a device malfunction, it is an incorrect configuration by the user.Due to the changed result being very far out of range, this was caught by a lab technician prior to being posted to a patients chart.The lab technicians are monitoring each result while the rule is being corrected to catch any erroneous results.The customer is continuing to investigate previous results from other patients where this configuration was present to determine if any patients were harmed.At this time, there is no report of patient harm.

• 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: 7857180
• MDR Text Key: 119688923
• Report Number: 1225673-2018-00009
• 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: Other
• Type of Report: Initial
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: V8.14.10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2016
• 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
• Patient Outcome(s): Other