VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T3 REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED TT3 RESULTS WERE OBTAINED FROM FOUR PATIENT SAMPLES WHILE USING THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE INVESTIGATION COULD NOT DETERMINE AN ASSIGNABLE CAUSE. BASED ON HISTORICAL QUALITY CONTROL RESULTS, THERE IS NO INDICATION OF A REAGENT ISSUE. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING/STORAGE OR THE PRESENCE OF AN UNKNOWN SAMPLE INTERFERENT CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTING FACTORS TO THE EVENT. AN ACCEPTABLE WITHIN RUN PRECISION TEST HAS VERIFIED THE CURRENT PERFORMANCE OF THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. HOWEVER, IT IS UNKNOWN IF THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WAS PERFORMING AS INTENDED WHEN THE INITIAL TESTING EVENT OCCURRED AND THEREFORE, AN INSTRUMENT ISSUE CANNOT BE ENTIRELY RULED OUT AS CONTRIBUTING TO THE EVENT. THE ASSIGNABLE CAUSE OF THIS EVENT IS UNKNOWN.

Description of Event or Problem

THE CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS TT3 RESULTS FROM FOUR PATIENT SAMPLES PROCESSED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WHEN COMPARED TO TT3 RESULTS OBTAINED FROM A NON-VITROS SYSTEM. PATIENT 1: >7.80 VERSUS EXPECTED 2.34 NG/ML. PATIENT 2: 3.51 VERSUS EXPECTED 1.73NG/ML. PATIENT 3: 2.81 VERSUS EXPECTED 1.31 NG/ML. PATIENT 4: 6.95 VERSUS EXPECTED 2.72 NG/ML. THE HIGHER THAN EXPECTED TT3 PATIENT RESULTS WERE REPORTED FROM THE LABORATORY AND BASED ON THE VITROS TT3 RESULTS, DOSE CHANGES IN DRUG TREATMENT (METHIMAZOLE AND LEVOTHYROXINE) WERE ADMINISTERED TO THE FOUR PATIENTS. CORRECTED REPORTS WERE ISSUED AFTER REPEAT TT3 TESTING WAS PERFORMED USING A NON-VITROS SYSTEM. IT WAS CONFIRMED THAT THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF FOUR MDR'S FOR THIS EVENT. FOUR 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS FOUR DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).