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

Model Number V8.15

Device Problem Loss of Data (2903)

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

Event Type  malfunction  

Event Description

A customer site upgraded instrument manager v8.13 to instrument manager v8.15.Site reported that test user fields are updating with information in them that was not present in previous version of instrument manager v8.13.The complaint was that a repeat sample is appearing in specimen management workspace when it should not.This affected workflows dependent on that test user field either having data or not having data to dictate reruns for tests that include hiv retesting.The site has not been able to provide a patient impact statement and will only be able to do so after exceeding the deadline to report to the fda.The development team intentionally made that change in instrument manager v8.14, so the software is behaving as expected.This is not a malfunction of instrument manager.

Event Description

A customer site upgraded instrument manager v8.13 to instrument manager v8.15.Site reported that test user fields are updating with information in them that was not present in previous version of instrument manager v8.13.The complaint was that a repeat sample is appearing in specimen management workspace when it should not.This affected workflows dependent on that test user field either having data or not having data to dictate reruns for tests that include hiv retesting.The site has not been able to provide a patient impact statement and will only be able to do so after exceeding the deadline to report to the fda.The development team intentiionally made that change in instrument manager v8.14, so the software is behaving as expected.This is not a malfunction of instrument manager.

Manufacturer Narrative

Instructions were provided to the customer describing how the rules behave in the upgraded instrument manager v8.15.The customer has reviewed all rules sets, and the only rule(s) affected by the issue is the one originally reported to data innovations.The customer reviewed results that were affected by this rule and determined there was no patient harm due to this issue.This was not a malfunction of instrument manager, and no patients were harmed.This was an omission of some instructions for use.

• 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: 8641531
• MDR Text Key: 146101287
• Report Number: 1225673-2019-00005
• 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: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1