VITROS XT CHEMISTRY PRODUCTS GLU-CA SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT A HIGHER THAN EXPECTED GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 7426-0023-0184 ON A VITROS XT 7600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS GLU LOT 7426-0023-0184 PERFORMANCE ISSUE IS NOT LIKELY A CONTRIBUTOR TO THE EVENT. HOWEVER, AN INDIVIDUAL SLIDE RELATED ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR. THE RESULTS OF VITROS ALKP PRECISION TESTING PERFORMED ON THE VITROS XT 7600 INTEGRATED SYSTEM WERE WITHIN ORTHO ACCEPTABLE GUIDELINES. IN ADDITION, THE EXPECTED (REPEAT) RESULT WAS OBSERVED BY THE CUSTOMER WITHOUT ANY CHANGE TO THE VITROS XT 7600 INTEGRATED SYSTEM. THEREFORE, AN INSTRUMENT RELATED ISSUE IS NOT A LIKELY CONTRIBUTING FACTOR OF THE EVENT. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS THE CUSTOMER IS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURERS RECOMMENDED CENTRIFUGATION PROTOCOL. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THE EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. PRE-ANALYTICAL SAMPLE MIX-UP WAS NOT A LIKELY CONTRIBUTOR TO THE EVENT, AS A REVIEW OF THE SAMPLE VISCOSITIES SHOWED SIMILAR RESULTS BETWEEN THE INITIAL AND REPEAT SAMPLES, INDICATING THAT THE SAME SAMPLE WAS PROCESSED.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 7426-0023-0184 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 528.0 MG/DL VS THE EXPECTED RESULT OF 78.0 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 RESULT WAS NOT REPORTED FROM THE LABORATORY. THE CUSTOMER HAS CONFIRMED THAT THERE HAS BEEN 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 (B)(4).