Instrument Manager Software

Description of Event or Problem

Roche Diagnostics, a Distributor of Instrument Manager, reported to Data Innovations on 23 JUN 2026 that Instrument Manager released a result of 'Negative' for 17 Treponemal tests. The User Facility expected a rule (user programmed logic) in Instrument Manager to hold tests where no results were received instead of releasing them with a result of 'Negative.'

Additional Manufacturer Narrative

Upon investigation conducted between the User Facility and Roche Diagnostics, a Distributor of Instrument Manager, it appears the Negative results were delivered incorrectly due to a user programmed logic error. For example, Roche Diagnostics identified an error in the way the rule was written which allowed tests that contained no results to be released as 'Negative' instead of being held for review. The Distributor confirmed they have corrected the issue with the user programmed logic and that the issue has been resolved. The User Facility confirmed they have removed the 17 affected results and notified providers of the incorrect results. Despite multiple attempts by Roche Diagnostics and Data Innovations to obtain further details, the User Facility was unable to determine if this error resulted in patient harm. While this is not a malfunction of Instrument Manager, this report is being submitted due to the facility's inability to provide a statement of patient impact caused by the user programmed logic error.