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

Model Number 8.17.30

Device Problem Insufficient Information (3190)

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

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

Upon investigation with the facility, it was determined that a result was generated on a test that was beyond the amr (reportable range) either low or high that contained a comment opposite than what was expected.The facility had a rule (user facility programmed logic) to report results less than the amr as

Event Description

A facility reported on 02sep2022 that a rule (user facility programmed logic) written caused a result to be released with the opposite value and comment than was expected.For example, a high microalbumin result was reported with a comment stating that the ratio could not be calculated because of a low result.The facility had written rules for test results above and below the analytical measurement range (amr) based upon the associated instrument error codes.According to the site, these rules functioned as intended prior to an instrument management server update.After the server update, the facility noted that the error code being used was being triggered for both high and low results, causing the rule to fire inappropriately.

• Brand Name: INSTRUMENT MANAGER
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): DATA INNOVATIONS LLC; 463 mountain view drive; colchester VT 05446
• Manufacturer Contact: sara shaw ; 463 mountain view drive; colchester, VT 05446 ; 8026582850
• MDR Report Key: 15524085
• MDR Text Key: 306428375
• Report Number: 1225673-2022-00009
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2022

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 Model Number: 8.17.30
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 10/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1