VITROS CHEMISTRY PRODUCTS VALP REAGENT

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD IMMUNOASSAY PLUS QUALITY CONTROL (QC) FLUIDS USING THE VITROS VALPROIC ACID (VALP) REAGENT LOT 2511-37-3554 PROCESSED ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS VALP BIORAD LEVEL 1 RESULTS OF <10, <10 UG/ML VERSUS THE EXPECTED RESULT OF 42 UG/ML VITROS VALP BIORAD LEVEL 3 RESULTS OF <10, <10 UG/ML VERSUS THE EXPECTED RESULT OF 122 UG/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 VITROS VALP RESULTS WERE OBTAINED USING QC FLUIDS. THERE WERE NO ALLEGATIONS OF HARM ASSOCIATED WITH THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF NON-VITROS BIORAD IMMUNOASSAY PLUS QUALITY CONTROL (QC) FLUIDS USING THE VITROS VALPROIC ACID (VALP) REAGENT LOT 2511-37-3554 PROCESSED ON A VITROS 4600 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED RESULTS IS UNKNOWN. VITROS VALP QC RESULTS WERE WITHIN EXPECTATION PRIOR TO BOTH EVENTS, INDICATING THAT AN ISSUE WITH VITROS VALP LOT 2511-37-3554 WAS NOT A LIKELY CONTRIBUTOR TO THE EVENT. NO INFORMATION WAS PROVIDED REGARDING THE STORAGE OR HANDLING OF THE QC FLUID IN USE, THEREFORE AN ISSUE ISOLATED TO THE QC FLUIDS CANNOT BE CONFIRMED OR RULED OUT AS A CONTRIBUTOR TO THE EVENT. THE LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO VITROS VALP LOT 2511-37-3554 REAGENT PACKS, PACK IDS 5976 AND 8373. AS THE CUSTOMER OBTAINED ACCEPTABLE RESULTS USING VITROS VALP REAGENT PACK IDS 5976 AND 8373 BEFORE AND/OR AFTER THE EVENTS, AN ISSUE WITH THE REAGENT PACKS IN USE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. NO DIAGNOSTIC PRECISION TESTING WAS PERFORMED ON THE VITROS 4600 SYSTEM AT THE TIME OF THE EVENTS, THEREFORE A TRANSIENT INSTRUMENT ISSUE CAN NOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT.