VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4280-1161-3070 ON A VITROS 350 CHEMISTRY SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE CUSTOMER INDICATED THAT PATIENT SAMPLES WERE AFFECTED, HOWEVER, NO PATIENT RESULTS WERE PROVIDED. THE CUSTOMER DID NOT PROVIDE ANY HISTORICAL QC RESULTS TO ACCESS THE PERFORMANCE OF NA SLIDE LOT 4280-1161-3070. THE CALIBRATION PARAMETERS IN USE AT THE TIME OF THE EVENT WERE NOT PROVIDED AND THEREFORE, A SUB-OPTIMAL CALIBRATION CANNOT BE CONFIRMED OR RULED OUT A POTENTIAL CONTRIBUTOR. THE ISSUE WAS RESOLVED WITH RECALIBRATION OF THE NA SLIDE LOT 4280-1161-3070. 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 4280-1161-3070 OR ANY OF THE VITROS PRODUCTS IN USE AT THE CUSTOMER SITE. THERE WAS NO INDICATION OF A MALFUNCTION WITH THE VITROS 350 CHEMISTRY SYSTEM AND AN INSTRUMENT ISSUE WAS NOT A LIKELY CONTRIBUTOR TO THE EVENT. THE ORTHO TSC REVIEWED THE CUSTOMERS PROTOCOL FOR PREPARING AND HANDLING THE VITROS NA+ REAGENT, VITROS CAL KIT 2 AND VITROS PV FLUIDS. THE ORTHO FIELD APPLICATION SPECIALIST STATED THAT THE CUSTOMER FOLLOWS THE RECOMMENDED PROTOCOLS LISTED IN THE PRODUCT(S) INSTRUCTIONS FOR USE (IFU).

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4280-1161-3070 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS PV I LOT E2828 RESULTS OF 141.4 AND 135.1 MMOL/L VS THE EXPECTED RESULT OF 125.8 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 NON-PATIENT CONTROL FLUID AND WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THAT PATIENT SAMPLES WERE AFFECTED, HOWEVER, NO NUMERICAL RESULTS WERE PROVIDED. THERE WERE NO REPORTS OF TREATMENT BEING INITIATED, ALTERED OR STOPPED BASED ON ANY BIASED VITROS NA+ RESULTS. THERE WAS NO REPORTED ALLEGATION 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 NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).