VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT DISCORDANT, HIGHER THAN EXPECTED FT3 RESULTS WERE OBTAINED FROM DIFFERENT SAMPLES FROM THE SAME PATIENT WHEN TESTED USING VITROS FT3 LOT 2330 ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM (REFURBISHED). THE RESULTS WERE DISCORDANT WHEN COMPARED TO FT3 RESULTS OBTAINED FROM NON-VITROS (BECKMAN, ROCHE AND SIEMENS) METHODS. A DELAY IN TREATMENT WAS CAUSED BY THE DISCORDANT, HIGHER THAN EXPECTED VITROS FT3 RESULTS. A DEFINITIVE CAUSE OF THE DISCORDANT, HIGHER THAN EXPECTED VITROS FT3 RESULTS WAS NOT ESTABLISHED. HISTORICAL QUALITY CONTROL RESULTS INDICATED ACCEPTABLE VITROS FT3 LOT 2330 REAGENT PERFORMANCE AND ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS FT3 LOT 2330. A VITROS ECI IMMUNODIAGNOSTIC SYSTEM INSTRUMENT ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT, AS PRECISION TESTING TO VERIFY THE PERFORMANCE OF THE INSTRUMENT WAS NOT CONDUCTED AROUND THE TIME OF THE EVENT. HOWEVER, PRECISION TESTING ON THE INSTRUMENT TESTING TEN DAYS AFTER THE EVENT WAS WITHIN ACCEPTABLE GUIDELINES. IN ADDITION, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS THE CUSTOMER IS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE¿S RECOMMENDATION FOR SAMPLE CENTRIFUGATION. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. HETEROPHILIC INTERFERENCE IS AN UNLIKELY CAUSE OF THE EVENT, AS VITROS FT3 TESTING USING A HETEROPHILIC BLOCKING TUBE DID NOT INDICATE THE PRESENCE OF A HETEROPHILIC INTERFERENT IN THE PATIENT'S SERUM.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT DISCORDANT, HIGHER THAN EXPECTED VITROS FREE T3 (FT3) RESULTS FROM TWO DIFFERENT SAMPLES FROM THE SAME PATIENT WHEN TESTED ON A VITROS ECI IMMUNODIAGNOSTIC SYSTEM (REFURBISHED). THE RESULTS WERE DISCORDANT WHEN COMPARED TO RESULTS OBTAINED FROM NON-VITROS (BECKMAN, ROCHE AND SIEMENS) METHODS. PATIENT 1 VITROS FT3 RESULTS OF 11.0, 9.8, 8.8 AND 9.63 PG/ML VERSUS THE NON-VITROS FT3 RESULTS OF 1.8, 2.17 AND 2.0 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE DISCORDANT, HIGHER THAN EXPECTED VITROS FT3 RESULTS WERE REPORTED FROM THE LABORATORY AND A KIDNEY TRANSPLANT WAS DELAYED DUE TO THE HIGHER THAN EXPECTED VITROS FT3 RESULTS. CORRECTED REPORTS WERE ISSUED FOLLOWING NON-VITROS (BECKMAN, ROCHE AND SIEMENS) FT3 RESULTS AND THE KIDNEY TRANSPLANT WENT AHEAD ON (B)(6) 2019. THE TSC STATED THE KIDNEY TRANSPLANT WAS SUCCESSFUL. A MEDICAL CONSULT FROM AN ORTHO MEDICAL SAFETY OFFICER CONCLUDED THAT NO SERIOUS HEALTH IMPACT IS EXPECTED DUE TO THE DELAYED KIDNEY TRANSPLANT. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. HOWEVER, IF A SIMILAR EVENT WERE TO OCCUR UNDETECTED, IT CANNOT BE CONCLUDED THAT THE LIKELIHOOD OF SERIOUS INJURY WOULD BE REMOTE. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).