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

Model Number V8.12.22

Device Problem Loss of Data (2903)

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

Event Type  malfunction  

Event Description

The helthcare facility wrote a configuration rule which was missing some parentheses in the rule.When instrument manager received a message from an instrument which contained 7 spaces, it caused the rule to fire erroneously.This changed the result of rubel test to "nni".The facility has not provided a patient impact statement of any investigation of results processed since the rule went live approximately one year ago.The facility has only stated that the one example they caught recently did not impact patient care.This is not a malfunction of instrument manager, this was a user configuration error.This report is being submitted to meet regulatory reporting requirements due to not being able to definitively state no patient harm occurred.If further information is provided regarding patient harm, an updated report will be submitted.

Manufacturer Narrative

Data innovations received additional information from the distributor on 03nov2018 stating their customer responded "i asked my senior chemistry specialist, she says this mistake cannot have caused patient death or serious injury, and there is no way to know if this rare error has happened before." the final determinations for this issue are that there was no malfunction of instrument manager, it was user error, and there is no patient harm.

Event Description

The healthcare facility wrote a configuration rule which was missing some parentheses in the rule.When instrument manager received a message from an instrument which contained 7 spaces, it caused the rule to fire erroneously.This changed the result of rubel test to "nni".The facility has not provided a patient impact statement of any investigation of results processed since the rule went live approximately one year ago.The facility has only stated that the one example they caught recently did not impact patient care.This is not a malfunction of instrument manager, this was a user configuration error.This report is being submitted to meet regulatory reporting requirements due to not being able to definitively state no patient harm occurred.If further information is provided regarding patient harm, an updated report will be submitted.

• 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: 8034290
• MDR Text Key: 126078644
• Report Number: 1225673-2018-00011
• 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: 11/02/2018

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: V8.12.22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 10/05/2018
• Supplement Dates FDA Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1