VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A DISCORDANT, LOWER THAN EXPECTED FREE T4 (FT4) RESULT WAS OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS FT4 LOT: 5940 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS DISCORDANT WHEN COMPARED TO VITROS FT4 RESULTS OBTAINED ON AN ALTERNATE VITROS 5600 INTEGRATED SYSTEM FOR THE SAME PATIENT SAMPLE. A DEFINITIVE CAUSE OF THE EVENT WAS NOT ESTABLISHED. AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT, AS THE DISCORDANT, LOWER THEN EXPECTED VITROS FT4 RESULT WAS ISOLATED TO A SINGLE RESULT ON THE CUSTOMER'S VITROS 5600 INTEGRATED SYSTEM AND REPRODUCIBLE VITROS FT4 RESULTS WERE OBTAINED FOR THE PATIENT SAMPLE ON THE CUSTOMER'S ALTERNATE VITROS 5600 INTEGRATED SYSTEM. THE PERFORMANCE OF THE VITROS 5600 INTEGRATED SYSTEM WAS NOT VERIFIED ON THE DATE OF THE EVENT, HOWEVER, WITHIN-RUN DIAGNOSTIC PRECISION TESTING FIVE DAYS FOLLOWING THE EVENT INDICATED ACCEPTABLE INSTRUMENT PERFORMANCE. PATIENT SAMPLE MIX UP CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT DUE TO MAGNITUDE OF DISCORDANCE OBSERVED BETWEEN THE VITROS FT4 RESULTS. HISTORICAL QC RESULTS INDICATE ACCEPTABLE ACCURACY OF THE VITROS FT4 LOT: 5940 REAGENT LEADING UP TO THE EVENT AND ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS FT4 REAGENT LOT: 5940.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, LOWER THAN EXPECTED FREE T4 (FT4) RESULT WAS OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS FT4 LOT: 5940 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS DISCORDANT WHEN COMPARED TO VITROS FT4 RESULTS OBTAINED ON AN ALTERNATE VITROS 5600 INTEGRATED SYSTEM FOR THE SAME PATIENT SAMPLE. PATIENT 1 RESULT OF <0.88 PMOL/L (HYPOTHYROID) VERSUS THE VITROS FT4 RESULTS OF 25.52 (EUTHYROID) AND 28.40 PMOL/L (HYPERTHYROID) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE DISCORDANT, LOWER THAN EXPECTED VITROS FT4 RESULT WAS REPORTED FROM THE LABORATORY, BUT NO TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED ON THE REPORTED RESULTS. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).