DADE ACTIN FSL

Additional Manufacturer Narrative

THE CAUSE FOR THE ELEVATED APTT RESULT IS UNKNOWN. A DADE BEHRING REPRESENTATIVE SERVICED THE DEVICE, DID NOT DETECT AN INSTRUMENT ISSUE AND WAS UNABLE TO DUPLICATE THE CUSTOMER PROBLEM. THE INSTRUMENT IS PERFORMING AS EXPECTED.

Description of Event or Problem

A FALSELY ELEVATED APTT RESULT OF 70.2 SECONDS WAS OBTAINED ON A SAMPLE FROM A PATIENT ON HEPARIN. RESULTS WERE REPORTED TO THE PHYSICIAN BEFORE FOLLOWING LAB PROTOCOL TO REPEAT THE TEST. THE SAMPLE WAS RETESTED WITH RESULTS OF 49.8 AND 49.5 SECONDS. THE PATIENT'S HEPARIN DOSE HAD BEEN CHANGED BASED ON THE ORIGINAL RESULT OF 70.2 SECONDS, THEN THE DOSE WAS CHANGED AGAIN WHEN THE CORRECTED PTT RESULTS WERE REPORTED. NO PATIENT HARM WAS NOTED. THE CAUSE FOR THE ELEVATED APTT RESULT IS UNKNOWN.