inforMED
MalfunctionJQP

INSTRUMENT MANAGER

Received Feb 18, 2026 · Event occurred Jan 19, 2026

Report 1225673-2026-00003 · MDR key 24383805

Device

Generic name

Calculator/data Processing Module

Product problems

  • Insufficient Device Problem Information

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON 19 JAN 2026, DATA INNOVATIONS WAS MADE AWARE BY A USER FACILITY THAT WHEN INSTRUMENT MANAGER RECEIVES A LABORATORY TEST RESULT FOR TOTAL PROTEIN, THERE IS AN INTERMITTENT ISSUE WHERE THE TEST RESULT IS NOT BEING ROUNDED AND IS SOMETIMES NOT BEING SENT TO THE INSTRUMENT. THE USER FACILITY EXPECTS INSTRUMENT MANAGER TO ROUND THE TOTAL PROTEIN RESULT AND SEND THIS ROUNDED RESULT TO ANOTHER INSTRUMENT.

Additional Manufacturer Narrative

WHEN THE USER FACILITY REPORTED TO DATA INNOVATIONS THAT A TEST RESULT WAS NOT BEING ROUNDED CORRECTLY, THE USER FACILITY PROVIDED EXAMPLE DATA THAT WAS REVIEWED BY DATA INNOVATIONS. UPON REVIEW OF THE EXAMPLES PROVIDED, DATA INNOVATIONS CONFIRMED THE TOTAL PROTEIN RESULT IS BEING ROUNDED BY INSTRUMENT MANAGER. TO FURTHER INVESTIGATE THE COMPLAINT THAT THE ROUNDED RESULT IS NOT BEING SENT TO THE INSTRUMENT, DATA INNOVATIONS REQUESTED COMMUNICATION LOGS TO DETERMINE IF INSTRUMENT MANAGER IS NOT COMMUNICATING THE RESULT AS EXPECTED. DESPITE MULTIPLE ATTEMPTS TO OBTAIN COMMUNICATION LOG DATA, DATA INNOVATIONS HAS NOT RECEIVED ANY NEW DATA FROM THE USER FACILITY AND IS UNABLE TO FURTHER TROUBLESHOOT THE COMPLAINT. THIS REPORT IS BEING SUBMITTED BECAUSE AS THE MANUFACTURER, DATA INNOVATIONS IS UNABLE TO RULE OUT OF MALFUNCTION OF INSTRUMENT MANAGER.