VITROS CHEMISTRY PRODUCTS CRP SLIDES

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED C-REACTIVE PROTEIN (CRP) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED DURING REAGENT LOT TO LOT CORRELATION TESTING USING VITROS CHEMISTRY PRODUCTS CRP SLIDE LOT 3748-1315-0558 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT RESULT OF 1.16 MG/DL VS AN EXPECTED RESULT OF 0.82 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 PATIENT RESULT WAS OBTAINED DURING A REAGENT LOT TO LOT CORRELATION TEST AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN NO ALLEGATIONS 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).

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED C-REACTIVE PROTEIN (CRP) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED DURING REAGENT LOT TO LOT CORRELATION TESTING USING VITROS CHEMISTRY PRODUCTS CRP SLIDE LOT 3748-1315-0558 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT. BASED ON QUALITY CONTROL RESULTS, A VITROS CRP LOT 3748-1315-0558 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR OF THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS CRP LOT 3748-1315-0558. AS A DIAGNOSTIC PRECISION TEST WAS NOT PERFORMED, A VITROS XT 7600 INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HOWEVER, THERE WAS NO INDICATION OF AN INSTRUMENT MALFUNCTION BY THE CUSTOMER. IN ADDITION, ACCEPTABLE QC RESULTS WERE OBSERVED ON THE DAY OF THE EVENT WITHOUT ANY ACTION BEING PERFORMED ON THE ANALYZER. THIS DEMONSTRATES THAT A VITROS XT 7600 INTEGRATED SYSTEM ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS THE CUSTOMER WAS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURERS RECOMMENDED CENTRIFUGATION PROTOCOL. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE CUSTOMER DID NOT CONFIRM HOW THE AFFECTED PATIENT SAMPLE WAS STORED BETWEEN TEST EVENTS WHICH OCCURRED ON DIFFERENT DATES (28 AND 29 JANUARY 2026). IT IS POSSIBLE THAT IMPROPER STORAGE OF THE AFFECTED PATIENT SAMPLE CONTRIBUTED TO THE EVENT, HOWEVER, THIS COULD NOT BE CONFIRMED.