VITROS IMMUNODIAGNOSTIC PRODUCTS SIGNAL REAGENT

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED NT-PROBNP II (NTBNP II) RESULT WAS OBTAINED WHEN PROCESSING A NON-VITROS BIORAD LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT QUALITY CONTROL (QC) FLUID LOT 1003102 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD QC LOT 1003102 QC FLUID RESULT OF 51.0 PG/ML VERSUS THE EXPECTED RESULT OF 153.2 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 LOWER-THAN-EXPECTED VITROS NTBNP II RESULT WAS OBTAINED WHEN PROCESSING NON-PATIENT FLUID. THE CUSTOMER MADE NO INDICATION THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED. THERE WERE NO REPORTED ALLEGATIONS OF 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).

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT A LOWER THAN EXPECTED NT-PROBNP II (NTBNP II) RESULT WAS OBTAINED WHEN PROCESSING A NON-VITROS BIORAD LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT QUALITY CONTROL (QC) FLUID LOT 1003102 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED QC FLUID RESULT WAS A TRANSIENT ISSUE WITH THE VITROS SIGNAL REAGENT PACK IN USE. A SIGNAL REAGENT (SR) WAS SUSPECTED TO CONTRIBUTE TO LOWER THAN EXPECTED VITROS NTBNP II RESULTS. AN ON-SITE INVESTIGATION WAS CONDUCTED, INCLUDING DATA COLLECTION AND COMPARISON OF THE VITROS NTBNP II REAGENT PERFORMANCE WITH OTHER VITROS MICROWELL REAGENTS. TEMPERATURE MONITORING CONFIRMED SR PACK STORAGE CONDITIONS WERE BETWEEN 3.9 DEGREES CELSIUS AND 5.1 DEGREES CELSIUS, MEETING THE REQUIRED 2-8 DEGREES CELSIUS RANGE. HOWEVER, IT REMAINS UNCLEAR WHETHER FREQUENT REFRIGERATOR DOOR OPENINGS IMPACTED THE SR REAGENTS STABILITY. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS NTBNP II REAGENT LOT 2150.