STAGO

Description of Event or Problem

ON (B)(6) 2011, PATIENT (PATIENT 1) SPECIMEN WAS TESTED ON STAGO 1 AND INDICATED A LONG FIBRINOGEN OF <60. THE NEXT PATIENT'S (PATIENT 2) FIBRINOGEN RESULT WAS THE SAME. REDRAWS WERE REQUESTED ON BOTH PATIENTS. THE REDRAW SPECIMENS FIBRINOGEN RESULTS ON BOTH PATIENTS WERE <60. REAGENTS WERE CHANGED, CONTROLS WERE RUN AND RESULTS WERE WITHIN ACCEPTABLE RANGE. THE REDRAW SPECIMENS WERE THEN RETESTED AND HAD THE SAME <60 RESULTS. PATIENT RESULTS WERE VERIFIED. LATER, TESTING WAS SWITCHED TO STAGO 2; REPEAT TESTING OF ALL PATIENT SPECIMENS INDICATED FIBRINOGEN VALUES WERE WITHIN NORMAL RANGE. A THIRD SPECIMEN WAS RECEIVED ON ONE OF THE PATIENTS, ALSO RUN ON STAGO 1 AND HAD A NORMAL RESULT. THIS SPECIMEN WAS PLACED ON STAGO 2 AND RETURNED A NORMAL RESULT. THE PREVIOUS 4 SPECIMENS WERE THEN RETESTED ON STAGO 1 AND TWO OF FOUR PATIENT SPECIMENS WERE WITHIN NORMAL RANGE, TWO SPECIMENS WERE <60. THE PROBLEM APPEARED TO BE RANDOM. NO OPERATIONAL ERROR CODES WERE INDICATED ON STAGO 1 OTHER THAN A MAXIMUM TIME ERROR. (PLEASE SEE ATTACHMENT 1: TECHNOLOGIST INFORMATION). PLEASE NOTE: MANUFACTURER PM ON THE INSTRUMENT (STAGE 1) HAD BEEN PERFORMED 4 DAYS BEFORE; NO PROBLEMS WERE REPORTED. WHEN THE MANUFACTURER'S TECHNICIAN CAME IN TO EXAMINE THE INSTRUMENT, AS PART OF THIS INVESTIGATION, HE FOUND THAT NEEDLES 1 AND 3 WERE HESITATING, WHICH THREW OFF THE TIMING OF THE TEST; HE REPLACED THE TUBING IN, AND THE CABLES ON, NEEDLES 1 AND 3. (PLEASE SEE ATTACHMENT 2: STAGO SERVICE DOCUMENTATION).