VITROS CHEMISTRY PRODUCTS GLU SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT HIGHER THAN EXPECTED GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0035-3247-5294 ON A VITROS 4600 CHEMISTRY SYSTEM. THE DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT IS USER ERROR. THE CUSTOMER DILUTED THE PATIENT SAMPLE PRIOR TO RUNNING ON THE VITROS 4600 CHEMISTRY SYSTEM. THE VITROS GLU INSTRUCTIONS FOR USE (IFU) STATES TO DILUTE IF GLUCOSE SERUM OR PLASMA CONCENTRATIONS EXCEED THE SYSTEM'S MEASURING (REPORTABLE OR DYNAMIC) RANGE. THE TSC REVIEWED E-CONNECTIVITY AND DID NOT FIND ANY RESULTS GREATER THAN THE VITROS GLU MEASURING RANGE THAT WOULD REQUIRE DILUTION. THE CUSTOMER WAS UNABLE TO STATE WHY THE SAMPLE WAS DILUTED. THE RESULTS OF VITROS ALKP WITHIN RUN DIAGNOSTIC PRECISION TESTING PERFORMED ON THE VITROS 4600 CHEMISTRY SYSTEM WERE WITHIN ACCEPTABLE GUIDELINES INDICATING THAT AN INSTRUMENT RELATED ISSUE WAS NOT A LIKELY CONTRIBUTOR OF THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS GLU REAGENT LOT 0035-3247-5294.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0035-3247-5294 ON A VITROS 4600 CHEMISTRY SYSTEM. PATIENT 1 SAMPLE RESULT OF 317.8 MG/DL VS AN EXPECTED RESULT OF 45.3 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS GLU RESULTS WERE NOT REPORTED FROM THE LABORATORY AND NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULTS. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 608913.