VITROS IMMUNODIAGNOSTIC PRODUCTS BRAHMS PCT REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED VITROS PROCALCITONIN (PCT) RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS THERMOFISHER MAS OMNI IMMUNE QUALITY CONTROL (QC) FLUIDS USING THE IN-USE LOT OF VITROS PCT REAGENT TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED VITROS PCT RESULTS COULD NOT BE DETERMINED. HISTORICAL QC FLUID RESULTS WERE ACCURATE AND PRECISE IN THE MONTH LEADING UP TO AND WEEKS DIRECTLY AFTER THE EVENT; THEREFORE, A VITROS PCT LOT 0416 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS PCT REAGENT LOT 0416. A DIAGNOSTIC VITROS TSH WITHIN-RUN PRECISION TESTING WAS PERFORMED ON 30 OCTOBER 2024 AND WAS WITHIN ORTHO ACCEPTABLE GUIDELINES. ALTHOUGH NO DIAGNOSTIC PRECISION TESTING WAS PERFORMED ON THE DAY OF THE EVENT, AN ANALYZER ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT AS HISTORICAL VITROS PCT QUALITY CONTROL RESULTS WERE ACCEPTABLE AND REPROCESSING OF MAS QC ON THE DAY OF THE EVENT YIELDED RESULTS WITHIN THE CUSTOMER'S ESTABLISHED RANGE. THE CUSTOMER COULD NOT CONFIRM NOR DENY IF THIS PRE-ANALYTICAL QC SAMPLE MIX UP HAD OCCURRED ON THE DATE OF THE EVENT. THEREFORE, PRE-ANALYTICAL QC FLUID MIX UP COULD NOT BE COMPLETELY RULED OUT AS A POTENTIAL CONTRIBUTOR TO THIS EVENT.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PROCALCITONIN (PCT) RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS THERMOFISHER MAS OMNI IMMUNE QUALITY CONTROL (QC) FLUIDS USING THE IN-USE LOT OF VITROS PCT REAGENT TESTED ON A VITROS 5600 INTEGRATED SYSTEM. MAS OMNI IMMUNE LEVEL 1 PCT RESULT OF < 0.03 AND < 0.03 NG/ML VS. THE EXPECTED RESULT OF 0.505 NG/ML MAS OMNI IMMUNE LEVEL 3 PCT RESULT OF < 0.03 NG/ML VS. THE EXPECTED RESULT OF 22.01 NG/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 LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION 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).