THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 250 CHEMISTRY SYSTEM. THE RESULT WAS HIGHER THAN EXPECTED WHEN COMPARED TO THE VITROS AMON RESULT OBTAINED FROM AN ALTERNATE SAMPLE COLLECTED FROM THE SAME PATIENT, TESTED ON THE SAME VITROS 250 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS MOST LIKELY DUE TO IMPROPER PRE-ANALYTICAL SAMPLE STORAGE OF PATIENT SAMPLE 1. PATIENT SAMPLE 1 WAS STORED AT ROOM TEMPERATURE FOR 30 MINUTES PRIOR TO TESTING. IN ADDITION, IT IS UNKNOWN IF THE PLASMA WAS SEPARATED FROM THE CELLULAR MATERIAL WITHIN 15 MINUTES OF COLLECTION. THE VITROS AMON IFU STATES THAT ROOM TEMPERATURE STORAGE IS NOT RECOMMENDED. AMMONIA IS A TIME SENSITIVE ASSAY DUE TO INCREASE IN AMMONIA CONCENTRATION AS THE SAMPLE AGES. THERE WAS NO INDICATION THE VITROS 250 SYSTEM MALFUNCTIONED. VITROS AMON PRECISION TESTING PERFORMED WAS WITHIN ACCEPTABLE GUIDELINES, SUGGESTING AN INSTRUMENT ISSUE WAS NOT LIKELY A CONTRIBUTING FACTOR. ADDITIONALLY, ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS AMON SLIDE LOT 1018-0249-9334. NO HISTORICAL QUALITY CONTROL RESULTS WERE PROVIDED, THEREFORE, AN UNEXPECTED PERFORMANCE ISSUE WITH VITROS AMON SLIDE LOT 1018-0249-9334 CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.
D
Patient 1
A CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULT FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 250 CHEMISTRY SYSTEM. THE RESULT WAS HIGHER THAN EXPECTED WHEN COMPARED TO THE VITROS AMON RESULT OBTAINED FROM AN ALTERNATE SAMPLE COLLECTED FROM THE SAME PATIENT, TESTED ON THE SAME VITROS 250 CHEMISTRY SYSTEM. PATIENT SAMPLE 1 VITROS AMON RESULT OF 725 UMOL/L VS. THE PATIENT SAMPLE 2 VITROS AMON RESULT OF 24 UMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE HIGHER THAN EXPECTED VITROS AMON RESULT WAS REPORTED OUTSIDE THE LABORATORY, BUT THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBERS (B)(4).