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

Model Number V8.15.11

Device Problem Loss of Data (2903)

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

Event Type  malfunction  

Event Description

End user reports an issue with fluid code being changed due to workflow.When there is a message from the remisol instrument that comes in to instrument manager as an order (per remisol specs) it is sent to the sebia instrument according to configuration.The request overwrites the original ordered fluid code with the remisol's fluid code.When sebia returns results back, the fluid code is no longer the same fluid as what was ordered, therefore it is not associated with the order that had the set specimen user fields, thus no specimen user fields are associated to that specimen.This is not a malfunction of instrument manager.Site gave a patient impact statement assuming a different root cause and data innovations has not been given an updated patient impact statement.There has been no report of patient harm, but the investigation has not concluded.

Event Description

End user reports an issue with fluid code being changed due to workflow.When there is a message from the remisol instrument that comes in to instrument manager as an order (per remisol specs) it is sent to the sebia instrument according to configuration.The request overwrites the original ordered fluid code with the remisol's fluid code.When sebia returns results back, the fluid code is no longer the same fluid as what was ordered, therefore it is not associated with the order that had the set specimen user fields, thus no specimen user fields are associated to that specimen.This is not a malfunction of instrument manager.Site gave a patient impact statement assuming a different root cause and data innovations has not been given an updated patient impact statement.There has been no report of patient harm, but the investigation has not concluded.

Manufacturer Narrative

The customer has been working with data innovations customer support department to determine the root cause.It has been determined that a poor workflow was the root cause.This was not a malfunction of instrument manager.Once the root cause was determined, the customer reevaluated previous results generated under this incorrect workflow and determined no patients were harmed as a result of 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: 8465649
• MDR Text Key: 145979631
• Report Number: 1225673-2019-00004
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

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: V8.15.11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/01/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1