INSTRUMENT MANAGER SOFTWARE
Received Mar 6, 2026 · Event occurred Feb 4, 2026
Report 1225673-2026-00004 · MDR key 24537394
Device
Generic name
Calculator/data Processing Module, For Clinical Use
Manufacturer
Data Innovations LlcProduct problems
- Computer Software Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
UPON INVESTIGATION WITH THE DISTRIBUTOR AND USER FACILITY, IT WAS DETERMINED THAT TWO VALUES USED WITHIN THE FREE TESTOSTERONE CALCULATION WERE NOT ENTERED AS INTENDED. FOR EXAMPLE, THE VALUES ENTERED FOR ALBUMIN UNIT CONVERSION AND ALBUMIN CONSTANT WERE INCORRECT. THE USER FACILITY HAD THE ALBUMIN UNIT CONVERSATION VALUE SET TO 6700 AND IT SHOULD HAVE BEEN 6900. THE USER FACILITY ALSO HAD THE ALBUMIN CONSTANT VALUE SET AT 30,000 INSTEAD OF 36,000. THE DISTRIBUTOR HAS ASSISTED THE USER FACILITY IN UPDATING THESE TWO VALUES AND IS VALIDATING THE CALCULATION WITH THE NEW VALUES. 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 PROGRAMMING ERROR OF THOSE VALUES.
Description of Event or Problem
ON 04 FEB 2026, DATA INNOVATIONS WAS MADE AWARE BY ABBOTT LABORATORIES, A DISTRIBUTOR OF INSTRUMENT MANAGER, THAT A USER FACILITY WAS QUESTIONING A CALCULATED RESULT FOR FREE TESTOSTERONE.