VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL T3 REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A SINGLE PEDIATRIC PATIENT SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T3 (TT3) REAGENT IN COMBINATION WITH A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO TT3 RESULTS OBTAINED FROM THE SAME SAMPLE TESTED ON A NON-VITROS ROCHE COBAS SYSTEM. THE MOST LIKELY CAUSE OF THE HIGHER THAN EXPECTED VITROS TT3 RESULTS IS THE PRESENCE OF A SAMPLE SPECIFIC INTERFERENT. TESTING USING A HETEROPHILIC BLOCKING TUBE IDENTIFIED THE PRESENCE OF A HETEROPHILIC SAMPLE INTERFERENT PRESENT IN THE SAMPLE. THE ISSUE IS ISOLATED TO THE SPECIFIC PATIENT SAMPLE IN QUESTION AND THERE IS NO INDICATION THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM OR VITROS TOTAL T3 REAGENT MALFUNCTIONED.

Description of Event or Problem

A CUSTOMER REPORTED HIGHER THAN EXPECTED RESULTS FROM A SINGLE PEDIATRIC PATIENT SAMPLE PROCESSED USING VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T3 (TT3) REAGENT IN COMBINATION WITH A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WHEN COMPARED TO TT3 RESULTS OBTAINED FROM THE SAME SAMPLE TESTED ON A NON-VITROS ROCHE COBAS SYSTEM. PATIENT SAMPLE 1 RESULTS OF 4.43 AND 4.15 NG/ML VS. THE EXPECTED RESULT OF 1.02 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. BASED ON THE HIGHER THAN EXPECTED VITROS TT3 RESULTS, THE PHYSICIAN REQUESTED AN ULTRASOUND ON THE PATIENT¿S THYROID GLAND AS A NODULE ON THE RIGHT-HAND SIDE OF THE GLAND WAS SUSPECTED. NO CHANGE IN THE PATIENTS METHIMAZOLE PRESCRIBED DOSE WAS MADE BASED ON THE VITROS TT3 RESULTS. THERE IS NO ALLEGATION OF ACTUAL PATIENT HARM, HOWEVER, ORTHO CANNOT CONCLUDE THAT SERIOUS INJURY OR HARM WOULD NOT OCCUR IF THIS INCIDENT WERE TO OCCUR AGAIN. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).