THE INVESTIGATION CONCLUDED THAT A LOWER THAN EXPECTED MYOG QUALITY CONTROL RESULT WAS OBTAINED USING A SINGLE NON-VITROS QUALITY CONTROL LEVEL IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT WAS USER ERROR, WHERE AN ATYPICAL ADJUSTMENT WAS PERFORMED DURING ROUTINE MAINTENANCE. ACCEPTABLE PERFORMANCE WAS OBTAINED AFTER SERVICE ACTIONS PERFORMED TO REPLACE, REPAIR, AND ADJUST COMPONENTS THERE IS NO INDICATION THAT A REAGENT ISSUE OR ATYPICAL PRE-ANALYTICAL SAMPLE HANDLING ARE CONTRIBUTING FACTORS TO THE EVENT.
D
Patient 1
THE CUSTOMER OBSERVED A LOWER THAN EXPECTED VITROS MYOG RESULT OBTAINED FROM A SINGLE NON-VITROS BIORAD QUALITY CONTROL FLUID PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD L1 CONTROL RESULT OF 107.457 NG/ML VERSUS CUSTOMER ESTABLISHED BASELINE MEAN 121.85 NG/ML. A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF IT WERE TO OCCUR UNDETECTED WITH PATIENT SAMPLES. ORTHO HAS NOT BEEN MADE AWARE OF ANY ERRONEOUS VITROS MYOG PATIENT RESULTS OBTAINED OR REPORTED FROM THE LABORATORY OVER THE TIME FRAME OF THE EVENT, HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS (ORTHO). (B)(4).