VITROS CHEMISTRY PRODUCTS GLU SLIDES

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) 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 0002-3259-4363 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 42.1 MG/DL VS AN EXPECTED RESULTS OF 282.2 AND 276.8 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LED 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 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 0002-3259-4363 ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON ACCEPTABLE HISTORICAL QUALITY CONTROL RESULTS, A VITROS GLU LOT 0002-3259-4363 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. ADDITIONALLY, 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 0002-3259-4363. THERE WAS NO INDICATION THAT THE VITROS 5600 SYSTEM MALFUNCTIONED. A DIAGNOSTIC VITROS GLU PRECISION TEST WAS WITHIN ORTHO ACCEPTABLE GUIDELINES, INDICATING THAT VITROS GLU LOT 0002-3259-4363 WAS PERFORMING AS EXPECTED IN COMBINATION WITH THE VITROS 5600 SYSTEM. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS IT IS 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 ALTHOUGH THIS COULD NOT BE CONFIRMED. A REVIEW OF THE PRESSURE PROFILES OF THE INDIVIDUAL PATIENT SAMPLE RUNS CONFIRMED THAT THERE WAS NO INDICATION THAT A PRE-ANALYTICAL PATIENT SAMPLE MIX-UP OCCURRED.