VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER USING VITROS CHEMISTRY PRODUCTS K+ SLIDES LOT: 4102-1153-4901 AND VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT: 4261-1141-5716 PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. AN ASSIGNABLE CAUSE OF EVENT 1 WAS UNABLE TO BE DETERMINED WITH THE INFORMATION PROVIDED. THE VITROS PV II RESULT FOR VITROS NA+ AS WELL AS THE VITROS PV I AND PV II RESULTS FOR VITROS K+ WERE WITHIN EXPECTATIONS AT THE TIME OF THE EVENT INDICATING THAT A REAGENT, INSTRUMENT OR FLUID RELATED ISSUE WERE NOT LIKELY CONTRIBUTING FACTORS OF THE EVENT. ADDITIONALLY, HISTORICAL QUALITY CONTROL RESULTS FOR VITROS NA+ LOT: 4261-1141-5716 WERE WITHIN EXPECTATIONS INDICATING THAT A VITROS NA+ REAGENT PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. HOWEVER, AN INDIVIDUAL SLIDE RELATED ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT. A POSSIBLE CAUSE OF THE EVENT IS A PRE-ANALYTICAL FLUID MIX-UP AS THE HIGH VITROS PV I RESULT OF 138.8 MMOL/L IS SIMILAR TO THE MIDPOINT OF THE ASSAY SHEET RANGE OF MEANS OF THE VITROS PV II LOT: D2338 FLUID FOR VITROS NA+ (139.4 MMOL/L). HOWEVER, THE CUSTOMER WAS UNABLE TO CONFIRM A FLUID MIX-UP. CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS NA+ REAGENT LOT: 4261-1141-5716. THE ASSIGNABLE CAUSE OF THE HIGHER-THAN-EXPECTED VITROS K+ AND NA+ RESULTS FOR EVENT 2 IS SUBOPTIMAL CALIBRATIONS. THE PARAMETERS FOR THE CALIBRATIONS WERE DETERMINED TO BE SUBOPTIMAL COMPARED TO THE DATABASE VALUES. THE CAUSE OF THE SUBOPTIMAL CALIBRATIONS IS UNKNOWN. THE TSC REVIEWED THE CUSTOMER'S PROTOCOL WHEN PREPARING AND HANDLING THE VITROS CAL KIT 2. THE CUSTOMER STATED THAT THEY FOLLOWED THE VITROS CAL KIT 2 INSTRUCTIONS FOR USE WHEN PREPARING THE FLUIDS. HOWEVER, AN ISSUE RELATED TO THE PREPARING AND HANDLING OF THE VITROS CAL KIT 2 FLUIDS CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTOR OF THE SUBOPTIMAL CALIBRATIONS. FOLLOWING A RECALIBRATION EVENT USING FRESHLY PREPARED VITROS CAL KIT 2 LOT: 0293 FLUIDS, QC RESULTS USING VITROS PV FLUIDS RETURNED TO EXPECTATIONS FOR BOTH VITROS NA+ AND K+.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) USING VITROS CHEMISTRY PRODUCTS K+ SLIDES LOT: 4102-1153-4901 AND VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT: 4261-1141-5716 PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. TWO SEPARATE EVENTS OCCURRED: EVENT 1: VITROS NA+ VITROS PV I LOT: B2245 RESULT OF 138.3 MMOL/L VS AN EXPECTED RESULT OF 116.4 MMOL/L EVENT 2: VITROS NA+ VITROS PV I LOT: B2245 RESULTS OF 138.3, 138.4, 139.2, 137.7, 137.4, 138.8, 138.0, 137.3 AND 138.4 MMOL/L VS AN EXPECTED RESULT OF 116.4 MMOL/L VITROS K+ VITROS PV I LOT: B2245 RESULTS OF 3.55, 3.59, 3.55, 3.52, 3.54, 3.55, 3.51, 3.53 AND 3.52 MMOL/L VS AN EXPECTED RESULT OF 2.89 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER-THAN-EXPECTED RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLES WERE PROCESSED AFTER THE UNACCEPTABLE QC RESULTS WERE OBTAINED. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF 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).