THE INVESTIGATION CONCLUDED THAT A HIGHER THAN EXPECTED RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS AMON MICRO SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION COULD NOT DETERMINE THE ASSIGNABLE CAUSE OF THE EVENT. THE SAMPLES WERE PROCESSED WITHIN 12 MINUTES ON BOTH SYSTEMS; THEREFORE, IMPROPER PRE-ANALYTICAL SAMPLE HANDING DID NOT LIKELY CONTRIBUTE TO THE EVENT. THERE WERE NO HISTORICAL QUALITY CONTROL RESULTS AVAILABLE TO ACCESS THE PERFORMANCE OF THE AMON LOT ON THE AFFECTED VITROS 5600 SYSTEM. HOWEVER, ONGOING TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD SUGGEST THERE IS A SYSTEMIC ISSUE WITH VITROS AMON REAGENT LOT 1017-0248-5923. A VITROS AMON WITHIN-RUN PRECISION TEST WAS ACCEPTABLE FOR BOTH ACCURACY AND PRECISION, INDICATING AN ANALYZER RELATED ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT. HOWEVER, ONLY A SINGLE LEVEL OF QUALITY CONTROL WAS PROCESSED FOR THE PRECISION TEST, AND IT IS UNKNOWN IF THE CALIBRATION IN USE WAS ACCEPTABLE ACROSS THE AMON MEASURING RANGE. THEREFORE, IT IS POSSIBLE THE EVENT WAS DUE TO CALIBRATION TO CALIBRATION VARIATION.
D
Patient 1
A CUSTOMER REPORTED UNEXPECTED RESULTS OBTAINED FROM A PATIENT SAMPLE CORRELATION PERFORMED BETWEEN TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS USING VITROS CLINICAL CHEMISTRY PRODUCTS AMMONIA (AMON) SLIDES. PATIENT SAMPLE RESULT OF 94 UMOL/L VS. THE EXPECTED RESULT OF 77 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED PATIENT SAMPLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).