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

Model Number 8.17.30.03

Device Problem Insufficient Information (3190)

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

Event Date 09/30/2022

Event Type  malfunction  

Manufacturer Narrative

The facility has a rule (user facility programmed logic) configured in instrument manager to calculate the glomerular filtration rate (egfr).The egfr rule calculation factors in the results of test a and test b combined with patient race and sex to determine the kidney function index.Where patient sex (m or f) should be populated, a seven digit-number is being populated within the rule.This change causes the rule to be unable to calculate the egfr and instead returns "comment" as the result.A technician at the facility identified the result of "comment" in the egfr result field rather than a numeric result.There was no patient harm as a result of this incident.Due to the facility configured data purge settings, specimen related data was not available for evaluation.Due to the lack of data and the inability to recreate this issue, the investigation has not yet determined with certainty if this was a malfunction of instrument manager software.

Event Description

A facility reported on (b)(6) 2022 that results from instrument manager are coming back incorrect.The facility has a rule (user facility programmed logic) configured in instrument manager to calculate the glomerular filtration rate (egfr).The sex of the patient is being returned as a numeric value which causes the rule to be unable to calculate the result and therefore returns "comment" as the result.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: CALCULATION/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: 15695376
• MDR Text Key: 306802099
• Report Number: 1225673-2022-00013
• 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: 10/28/2022

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: 8.17.30.03
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1