MAUDE Adverse Event Report: DATA INNOVATIONS, LLC INSTRUMENT MANAGER SOFTWARE; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number 8.16.00.20

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  malfunction  

Event Description

A laboratory user reported on (b)(6) 2020 that after upgrading their data innovations instrument manager software from (b)(4), the hemoglobin a1c test at one location had 43 patient results sent to the laboratory information system (lis) that were inaccurate and required manual correction in the lis.According to the site, it appears that this was due to an incorrect configuration of a test code mapping.Once the test code mapping was corrected by the user, the problem has not occurred again.The lab manager reported that they were able to correct the erroneous results in the lis and confirmed there was no patient harm.It has not yet been determined if this is a malfunction of the software or a configuration error by the user.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): DATA INNOVATIONS, LLC; 120 kimball ave; suite 100; south burlington, vt
• Manufacturer Contact: matthew smith ; 120 kimball ave; suite 100; south burlington, vt ; 6582850
• MDR Report Key: 10490736
• MDR Text Key: 241095257
• Report Number: 1225673-2020-00003
• 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: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2020

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: 8.16.00.20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1