INSTRUMENT MANAGER SOFTWARE
Received Jul 2, 2026 · Event occurred Jun 3, 2026
Report 1225673-2026-00008 · MDR key 25696096
Device
Generic name
Calculator/data Processing Module, For Clinical Use
Manufacturer
Data Innovations LlcProduct problems
- Computer Software Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
A USER FACILITY REPORTED TO DATA INNOVATIONS ON 03 JUN 2026 THAT A QUALITY CONTROL ERROR CODE OF 1-3S APPEARED ON THEIR TEST RESULT AND REQUESTED INVESTIGATION AS TO WHY THE ERROR CODE WAS POPULATED.
Additional Manufacturer Narrative
A USER FACILITY REPORTED TO DATA INNOVATIONS THAT A QUALITY CONTROL ERROR CODE OF 1-3S APPEARED ON THEIR TEST RESULT AND REQUESTED ASSISTANCE FROM THE MANUFACTURER. HOWEVER, THE USER FACILITY DID NOT PROVIDE ADDITIONAL INFORMATION OR USABLE DATA TO REVIEW THE ISSUE. DESPITE MULTIPLE ATTEMPTS TO OBTAIN FURTHER DETAILS, DATA INNOVATIONS HAS BEEN UNABLE TO TROUBLESHOOT OR ASSIST IN RESOLVING THE COMPLAINT. THIS REPORT IS BEING SUBMITTED BECAUSE AS THE MANUFACTURER, DATA INNOVATIONS IS UNABLE TO RULE OUT MALFUNCTION OR PATIENT HARM.