VITROS IMMUNODIAGNOSTIC PRODUCTS SIGNAL REAGENT

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT A LOWER THAN EXPECTED VITROS NTBNP II RESULT WAS OBTAINED WHEN PROCESSING A NON-VITROS QUALAB BIOTECH QUALITY CONTROL (QC) FLUID LOT 2510A05423 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS AN ISSUE RELATED TO THE VITROS SIGNAL REAGENT (SR) PACK IN USE AT THE TIME OF THE EVENT. THE INVESTIGATION FOUND THAT A NEWLY REPLACED SIGNAL REAGENT HAD BEEN STORED IN AN AREA THAT DID NOT HAVE THE CORRECT TEMPERATURE SETTINGS. TEMPERATURE MONITORING REVEALED STORAGE CONDITIONS EXCEEDED 9 DEGREES CELSIUS, REACHING 10 DEGREES CELSIUS INSIDE THE REAGENT KIT, WHICH LIKELY COMPROMISED REAGENT STABILITY AND CAUSED THE LOWER THAN EXPECTED VITROS NTBNP II QC RESULT. ACCORDING TO THE VITROS SIGNAL REAGENT INSTRUCTIONS FOR USE, THE PACKS SHOULD BE STORED AT 2 - 8 DEGREES CELSIUS. IT WAS CONCLUDED THAT THE ELEVATED STORAGE TEMPERATURE LIKELY AFFECTED THE STABILITY OF THE SIGNAL REAGENT, RESULTING IN LOW QUALITY CONTROL RESULTS. THE SUSPECT VITROS SIGNAL REAGENT PACK WAS REPLACED AND ASSAY RESULTS RETURNED TO EXPECTATIONS. THE REST OF THE VITROS SIGNAL REAGENT WAS RELOCATED TO A MORE TEMPERATURE-STABLE AREA, AND ONGOING MONITORING WAS IMPLEMENTED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS NTBNP II REAGENT LOT 2080.

Description of Event or Problem

THE INVESTIGATION HAS DETERMINED THAT A LOWER-THAN-EXPECTED NT PROBNP II (NTBNP II) RESULT WAS OBTAINED WHEN PROCESSING A NON-VITROS QUALAB BIOTECH QUALITY CONTROL (QC) FLUID LOT 2510A05423 ON A VITROS 5600 INTEGRATED SYSTEM. BIOTECH LOT 2510A05423 = 159.0 PG/ML VERSUS THE EXPECTED RESULT OF 352.67 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED VITROS NTBNP II RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).