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

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2021

Event Type  malfunction  

Event Description

A laboratory user reported on (b)(6) 2021 that critical results are not being held in instrument manager (im) when they should have been held.Also, results that should have passed validation and released are being held.The laboratory user has stated being unaware of this issue occurring since the initial issue was reported.The investigation is pending data being provided from the site upon the next occurrence.There was no patient harm as this was a one time occurrence, and laboratory staff are made aware when the issue happens.The investigation has been unable to reproduce the issue and therefore, it cannot be determined if this is a malfunction of the instrument manager software.The investigation is ongoing at the time of this report.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, PRODUCT
• Manufacturer (Section D): DATA INNOVATIONS LLC; 463 mountain view drive; colchester VT 05446
• Manufacturer Contact: erika humphrey ; 463 mountain view drive; colchester, VT 05446 ; 8026582850
• MDR Report Key: 12522980
• MDR Text Key: 273141443
• Report Number: 1225673-2021-00011
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2021

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: No Information
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1