VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT: 4282-1162-3122 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS PV I E2828 RESULTS OF 139.7, 138.8 AND 140.2 MMOL/L VS. THE EXPECTED RESULT OF 126.2 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 NA+ RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND NO RESULTS WERE REPORTED FROM THE LABORATORY. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT HIGHER THAN EXPECTED SODIUM RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT: 4282-1162-3122 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS IMPROPER PROTOCOL PERFORMED BY THE CUSTOMER WHEN PREPARING AND USING THE VITROS PRODUCTS. THE CUSTOMER WAS NOT WARMING THE VITROS NA+ SLIDE CARTRIDGES FOR THE REQUIRED AMOUNT OF TIME AFTER REMOVING THEM FROM STORAGE AND BEFORE LOADING AND USING THEM ON THE VITROS 5600 SYSTEM. ADDITIONALLY, THE CUSTOMER WAS WARMING THE VITROS CALIBRATOR KIT 2 AND VITROS PERFORMANCE VERIFIER VIALS LONGER THAN RECOMMENDED AND WAS NOT RECONSTITUTING THE VIALS AS RECOMMENDED IN THE PRODUCT INSTRUCTIONS FOR USE. AFTER USING FRESH VITROS PRODUCTS PREPARED BY FOLLOWING THE PRODUCT(S) INSTRUCTIONS FOR USE, VITROS NA+ RESULTS RETURNED TO EXPECTATIONS FOR THE CUSTOMER.