VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT THREE HIGHER THAN EXPECTED VITROS TROPONIN I ES (TROPI ES) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND TWO HIGHER THAN EXPECTED VITROS NT ¿ PROBNP (NTBNP) RESULTS WERE OBTAINED FROM THE SAME PATIENT SAMPLE WHEN TESTED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS TROPI ES LOT 3360 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. HOWEVER, THE CUSTOMER DOES NOT PROCESS A CONTROL FLUID WITH A TROPONIN I CONCENTRATION AT, OR BELOW THE URL. THEREFORE, THE PERFORMANCE OF THE VITROS TROPI ES REAGENT LOT 3360 AT, OR BELOW THE URL CONCENTRATION OF 0.034 NG/ML CANNOT BE DETERMINED AND A VITROS TROPI ES LOT 3360 REAGENT ISSUE COULD NOT BE ENTIRELY RULED OUT AS CONTRIBUTING TO THE EVENT. ADDITIONALLY, A VITROS NTBNP LOT 2170 REAGENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT, AS DESPITE THE ACCURACY OF THE HISTORICAL QUALITY CONTROL RESULTS BEING WITHIN ACCEPTABLE GUIDELINES, THE QUALITY CONTROL DATA EXHIBITED POOR WITHIN LABORATORY PRECISION. HOWEVER, ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS TROPI ES REAGENT LOT 3360 OR VITROS NTBNP LOT 2170. PRECISION TESTING PERFORMED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM WAS NOT COMPLETED ACCORDING TO ORTHO GUIDELINES AND THEREFORE, IT IS NOT POSSIBLE TO COMPLETELY RULE OUT AN INSTRUMENT ISSUE AS A POTENTIAL CONTRIBUTOR TO THE EVENTS. IN ADDITION, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS NOT POSSIBLE TO ESTABLISHED IF THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE¿S RECOMMENDATION FOR SAMPLE CENTRIFUGATION AND CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS LIKELY PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED.

Description of Event or Problem

A CUSTOMER OBTAINED THREE HIGHER THAN EXPECTED VITROS TROPONIN I ES (TROPI ES) RESULTS FROM A SINGLE PATIENT SAMPLE AND TWO HIGHER THAN EXPECTED VITROS NT ¿ PROBNP (NTBNP) RESULTS FROM THE SAME PATIENT SAMPLE WHEN TESTED ON A VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. PATIENT SAMPLE 1 TROPI ES RESULTS OF 9.48, 5.56 AND 1.00 NG/ML VERSUS THE EXPECTED RESULT OF 0.012 NG/ML. PATIENT SAMPLE 1 NT-PROBNP RESULTS OF 1900 AND 473 PG/ML VS. EXPECTED RESULT OF 125 PG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE HIGHER THAN EXPECTED VITROS TROPI ES RESULT OF 5.56 NG/ML AND THE VITROS NTBNP RESULT OF 1900 PG/ML WERE BOTH REPORTED FROM THE LABORATORY. THE PATIENT WAS SENT TO A LARGER HOSPITAL FACILITY BASED ON THESE REPORTED VITROS RESULTS. A FURTHER TROPONIN I ES TEST AND A VITROS NT-PROBNP TEST WAS PERFORMED AND RETURNED NEGATIVE RESULTS FOR BOTH TESTS. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4).