Quality control lockout function on Medtronic ACT Plus coagulation timer system can be bypassed for same-patient...

Area of Science:

• Medical Device Technology
• Clinical Pathology
• Laboratory Medicine

Background:

• The Medtronic ACT Plus automated coagulation timer system is used for activated clotting time (ACT) analysis.
• Quality control (QC) is essential for ensuring the accuracy of diagnostic test results.

Purpose of the Study:

• To identify a potential malfunction in the Medtronic ACT Plus system's QC lockout function.
• To alert users to a critical issue that may compromise patient safety.

Main Methods:

• Investigated the behavior of the Medtronic ACT Plus system when QC has not been performed.
• Observed the system's response to sample analysis requests following overdue QC intervals.

Main Results:

• The ACT Plus system's QC lockout function may fail to activate on single-patient use.
• The device provides an alert (beeping and on-screen message) but proceeds with sample analysis.
• This can result in the reporting of inaccurate ACT results.

Conclusions:

• Inaccurate ACT results can lead to incorrect and potentially dangerous heparin therapy decisions.
• Users must be aware that the device may not enforce QC checks.
• It is crucial for users to manually verify QC completion before analyzing patient samples.