VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED CK-MB RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT LOT 3980 ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS CK-MB REAGENT LOT 3980 PERFORMANCE ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENT. PRECISION TESTING WAS NOT PERFORMED ON THE VITROS 5600 INTEGRATED SYSTEM TO VERIFY PERFORMANCE UPON REQUEST. THEREFORE, AN INSTRUMENT RELATED ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTOR OF THE EVENT. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS IT IS UNKNOWN IF THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURERS RECOMMENDED CENTRIFUGATION PROTOCOL. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THE EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. ADDITIONALLY, AS E-CONNECTIVITY DATA WAS NOT ABLE TO BE REVIEWED FOR THE CUSTOMER SITE, A PREANALYTICAL SAMPLE MIX-UP COULD NOT BE CONFIRMED OR RULED OUT AS A CAUSE OF THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS CK-MB REAGENT LOT 3980.

Description of Event or Problem

A FIELD APPLICATION SPECIALIST (FAS), ON BEHALF OF A CUSTOMER, CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED CK-MB RESULT OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT LOT 3980 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 100.0 NG/ML VS. THE EXPECTED RESULT OF 0.42 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS CK-MB RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE HAVE BEEN NO ALLEGATIONS 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).