INSTRUMENT MANAGER SOFTWARE
Received Feb 11, 2026 · Event occurred Jan 12, 2026
Report 1225673-2026-00002 · MDR key 24318206
Device
Generic name
Blood Establishment Computer Software And Accessories
Manufacturer
Data Innovations LlcProduct problems
- Computer Software Problem
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 12 JAN 2026, DATA INNOVATIONS WAS MADE AWARE BY A USER FACILITY THAT THE RULE THEY ARE USING TO CALCULATE PATIENT AGE DOES NOT LEAD TO THE CORRECT RESULT. THE CUSTOMER EXPECTED THE RULE TO NOT ROUND TO THE NEAREST WHOLE NUMBER.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: DATA INNOVATIONS HAS RECEIVED CONFIRMATION FROM THE USER FACILITY THAT NO PATIENT HARM HAS OCCURRED DUE TO THIS USER PROGRAMMED LOGIC ERROR. INFORMATION FROM ORIGINAL REPORT: UPON INVESTIGATION WITH THE FACILITY, IT WAS DETERMINED THAT RULES (USER PROGRAMMED LOGIC) WERE NOT FUNCTIONING AS INTENDED DUE TO THE PROGRAMMING OF THOSE RULES. FOR EXAMPLE, THE RULES USED 'AGE IN YEARS' VALUE AND WHEN THIS IS USED, INSTRUMENT MANAGER ONLY RECOGNIZES WHOLE NUMBERS. DATA INNOVATIONS LLC IDENTIFIED THE USER FACILITY SHOULD BE USING THE 'AGE IN DAYS' ALONG WITH DATE AND TIME USER FIELDS TO APPROPRIATELY OBTAIN THE DESIRED ROUNDING. ONCE THE RESULT OF THE ERROR WAS LOCATED, DATA INNOVATIONS ASSISTED THE USER FACILITY IN CORRECTING THE RULE TO CALCULATE THE AGE. WHILE THIS IS NOT A MALFUNCTION OF THE INSTRUMENT MANAGER MEDICAL DEVICE IT IS BEING REPORTED DUE TO THE FACILITIES INABILITY TO PROVIDE A STATEMENT OF PATIENT IMPACT DUE TO THE USER PROGRAMMED LOGIC ERROR.
Additional Manufacturer Narrative
UPON INVESTIGATION WITH THE FACILITY, IT WAS DETERMINED THAT RULES (USER PROGRAMMED LOGIC) WERE NOT FUNCTIONING AS INTENDED DUE TO THE PROGRAMMING OF THOSE RULES. FOR EXAMPLE, THE RULES USED 'AGE IN YEARS' VALUE AND WHEN THIS IS USED, INSTRUMENT MANAGER ONLY RECOGNIZES WHOLE NUMBERS. DATA INNOVATIONS LLC IDENTIFIED THE USER FACILITY SHOULD BE USING THE 'AGE IN DAYS' ALONG WITH DATE AND TIME USER FIELDS TO APPROPRIATELY OBTAIN THE DESIRED ROUNDING. ONCE THE RESULT OF THE ERROR WAS LOCATED, DATA INNOVATIONS ASSISTED THE USER FACILITY IN CORRECTING THE RULE TO CALCULATE THE AGE. WHILE THIS IS NOT A MALFUNCTION OF THE INSTRUMENT MANAGER MEDICAL DEVICE IT IS BEING REPORTED DUE TO THE FACILITIES INABILITY TO PROVIDE A STATEMENT OF PATIENT IMPACT DUE TO THE USER PROGRAMMED LOGIC ERROR.
Description of Event or Problem
ON (B)(6) 2026, DATA INNOVATIONS WAS MADE AWARE BY A USER FACILITY THAT THE RULE THEY ARE USING TO CALCULATE PATIENT AGE DOES NOT LEAD TO THE CORRECT RESULT. THE CUSTOMER EXPECTED THE RULE TO NOT ROUND TO THE NEAREST WHOLE NUMBER.