VITROS CHEMISTRY PRODUCTS ELECTROLYTE REFERENCE FLUID

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED POTASSIUM RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) AND HIGHER THAN EXPECTED SODIUM RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER AND FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID WHEN PROCESSED USING VITROS CHEMISTRY PRODUCTS K+ SLIDES LOT 4102-1030-6347 AND VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4227-1027-6000 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS AN UNKNOWN ISSUE WITH VITROS CHEMISTRY PRODUCTS ELECTROLYTE REFERENCE FLUID (ERF) LOT V7952. HISTORICAL QUALITY CONTROL RESULTS WERE NOT ACCEPTABLE THROUGH THE TIMEFRAME THIS ERF LOT WAS IN USE. AFTER AN ALTERNATE LOT OF ERF (X8037) WAS PUT INTO USE, QUALITY CONTROL RESULTS RETURNED TO EXPECTATIONS. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS ERF LOT V7952. QUALITY CONTROL RESULTS OBTAINED AFTER A CALIBRATION EVENT USING LOT X8037 OF VITROS ERF INDICATE VITROS K+ LOT 4102-1030-6347 AND VITROS NA+ LOT 4227-1027-6000 IN COMBINATION WITH THE VITROS 5600 INTEGRATED SYSTEM ARE PERFORMING AS EXPECTED. THE CUSTOMER CONFIRMED THAT THEY ARE FOLLOWING ORTHO RECOMMENDATIONS FOR WARMING THE ERF PRIOR TO LOADING AND PROCESSING, THEREFORE, AN ISSUE RELATED TO PROTOCOL IS NOT A LIKELY CONTRIBUTING FACTOR OF THE EVENT. DIAGNOSTIC WITHIN RUN VITROS NA+ PRECISION TEST RESULTS WERE ACCEPTABLE INDICATING THE VITROS 5600 INTEGRATED SYSTEM WAS PERFORMING AS INTENDED AND WAS NOT LIKELY A CONTRIBUTOR OF THE EVENT.

Description of Event or Problem

A CUSTOMER REPORTED HIGHER THAN EXPECTED POTASSIUM RESULTS OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) AND HIGHER THAN EXPECTED SODIUM RESULTS OBTAINED FROM A VITROS PERFORMANCE VERIFIER AND FROM A NON-VITROS BIORAD QUALITY CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS K+ SLIDES AND VITROS CHEMISTRY PRODUCTS NA+ SLIDES IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. VITROS PV I LOT N7648 VITROS K+ RESULT OF 3.67 MMOL/L VS AN EXPECTED VITROS K+ RESULT OF 2.99 MMOL/L. BIORAD LOT 45830 L1 VITROS NA+ RESULT OF 149.7 MMOL/L VS AN EXPECTED VITROS NA+ RESULT OF 116.0 MMOL/L. VITROS PV I LOT N7648 VITROS NA+ RESULTS OF 139.4 AND 152.2 MMOL/L VS AN EXPECTED VITROS NA+ RESULT OF 117.9 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 VITROS K+ AND VITROS NA+ RESULTS WERE OBTAINED WHEN TESTING QUALITY CONTROL FLUIDS. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDR¿S 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. COMPLAINT NUMBER (B)(4).