VITROS IMMUNODIAGNOSTIC PRODUCTS CKMB REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT A HIGHER THAN EXPECTED VITROS CKMB RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 SYSTEM WHEN COMPARED TO A NON-VITROS ABBOTT CKMB RESULT. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN WITH THE INFORMATION PROVIDED. THE CUSTOMER DID NOT PERFORM ANY ADDITIONAL TESTING RESULTS USING APPROPRIATE BLOCKING TUBES, THEREFORE, THE PRESENCE HETEROPHILIC ANTIBODY SAMPLE INTERFERENT CAUSING THE HIGHER THAN EXPECTED VITROS CKMB RESULT CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. THE CUSTOMER DOES NOT TEST QUALITY CONTROL FLUIDS TO ASSESS THE PERFORMANCE OF THE VITROS CKMB ASSAY. THEREFORE, A VITROS CKMB REAGENT PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS CKMB REAGENT LOT 3270. THE CUSTOMER MADE NO ALLEGATION THAT THERE WAS ISSUE WITH THE PERFORMANCE OF THE VITROS 5600 INTEGRATED SYSTEM, HOWEVER, SINCE NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED WITHIN THE TIMEFRAME OF THE EVENT. THEREFORE, AN INSTRUMENT RELATED PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. IN ADDITION, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS ESTABLISHED THE CUSTOMER WAS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE¿S RECOMMENDATION FOR SAMPLE CENTRIFUGATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS CKMB RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 5600 SYSTEM WHEN COMPARED TO A NON-VITROS ABBOTT CKMB RESULT. PATIENT SAMPLE RESULT OF 170 NG/ML VS. THE EXPECTED RESULT OF 0.60 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS CKMB RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER #: (B)(4) AND REPORTABILITY ASSESSMENT: (B)(4).