VITROS CHEMISTRY PRODUCTS GLU SLIDES

Description of Event or Problem

AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) FIELD APPLICATION SPECIALIST (FAS) CONTACTED THE ORTHO TECHNICAL SOLUTIONS CENTER (TSC) ON BEHALF OF A CUSTOMER TO REPORT A NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0036-3248-5953 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 2.42 MMOL/L VS AN EXPECTED RESULT OF 12.88 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED VITROS GLU RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE HAVE BEEN NO REPORTED 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 HAS DETERMINED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE (GLU) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLU SLIDES LOT 0036-3248-5953 ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS GLU LOT 0036-3248-5953 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 GLU PRECISION TESTING PERFORMED ON THE VITROS 5600 INTEGRATED SYSTEM WERE WITHIN ORTHO ACCEPTABLE GUIDELINES. IN ADDITION, THE EXPECTED RESULT WAS REPRODUCED BY AN ORTHO FIELD APPLICATION SPECIALIST WITHOUT ANY CHANGE TO THE VITROS 5600 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 IT WAS UNKNOWN IF THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURER'S 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. 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 0036-3248-5953.