VITROS CHEMISTRY PRODUCTS GLU SLIDES

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN COMPARED TO THE VITROS GLU RESULT OBTAINED FROM A RETEST EVENT USING THE SAME PATIENT SAMPLE TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULTS OF 491.6, 233.5, AND 240.2 MG/DL VS THE EXPECTED RESULT OF 125.7 MG/DL BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLU RESULT OF 491.6 MG/DL WAS REPORTED FROM THE LABORATORY AND QUESTIONED BY A PHYSICIAN. THE SAMPLE WAS REPROCESSED AND A CORRECTED REPORT WAS LATER ISSUED. IT IS UNKNOWN IF TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED RESULT THAT WAS RELEASED. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS GLUCOSE (GLU) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN COMPARED TO THE VITROS GLU RESULT OBTAINED FROM A RETEST EVENT USING THE SAME PATIENT SAMPLE TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED RESULT OF 491.6 WAS PRE-ANALYTICAL SAMPLE MIX-UP. FINAL ZEE MEASUREMENT DATA DEMONSTRATED THAT THE VITROS GLU RESULTS OBTAINED FROM TEST EVENT 1 COULD NOT HAVE BEEN OBTAINED FROM THE SAME PATIENT SAMPLE THAT PRODUCED THE VITROS GLU RESULTS FOR TEST EVENTS 2 AND 3. THE Z HEIGHT MEASUREMENT SHOULD DECREASE AS FLUID IS TAKEN OUT OF A SAMPLE CONTAINER, HOWEVER IN THIS CASE TEST EVENTS 2 AND 3 SHOWED A GREATER Z HEIGHT THAN TEST EVENT 1. ADDITIONALLY, THE ANALYTE RESULTS FROM TEST EVENT 5 (WHICH THE CUSTOMER CONSIDERED THE EXPECTED RESULT FOR THE PATIENT) DID NOT COMPARE WELL WITH TEST EVENT 1. AS THE ERRONEOUS RESULT OF 491.6 MG/DL WAS A RESULT OF SAMPLE MIX-UP CAUSED BY PRE-ANALYTICAL ERROR THAT OCCURRED PRIOR TO THE SAMPLE BEING PROGRAMMED OR LOADED ON THE INSTRUMENT, THIS RESULT IS THEREFORE NOT REPORTABLE ACCORDING TO WKI53815: INSTRUCTIONS FOR HEALTH AND SAFETY REPORTABILITY GUIDELINES FOR CLINICAL LABORATORY PRODUCTS. THE VITROS XT 7600 INTEGRATED SYSTEM DID NOT MALFUNCTION. A DEFINITIVE ASSIGNABLE CAUSE OF THE RESULTS FROM TEST EVENT 2 AND TEST EVENT 3 COULD NOT BE DETERMINED. IT WAS CONFIRMED THAT A PREANALYTICAL PATIENT SAMPLE MIX UP WAS THE ATTRIBUTABLE CAUSE FOR THE RESULT FROM TEST EVENT 1 WHICH ALSO SUGGESTS THAT ANOTHER PREANALYTICAL PATIENT SAMPLE MIX WAS POSSIBLE FOR TEST EVENTS 2 AND 3, GIVEN THAT USER ERROR WAS ALREADY CONFIRMED DURING THIS INVESTIGATION. IN ADDITION, THE FACT THAT THIS PATIENT HAS NO HISTORY OF DIABETES AND THE RESULTS FROM TEST EVENTS 4, 5, AND 6 DID NOT REPRODUCE THE RESULTS FROM TEST EVENTS 2 AND 3 FURTHER POINTS TO A PRE-ANALYTICAL PATIENT SAMPLE MIX UP AS THE LIKELY ATTRIBUTABLE CAUSE OF THIS EVENT, HOWEVER THIS COULD NOT BE CONFIRMED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS GLU LOT 0035-3247-5294 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 PRECISION TESTING PERFORMED ON THE VITROS XT 7600 INTEGRATED SYSTEMS WERE WITHIN ORTHO ACCEPTABLE GUIDELINES. 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 WAS NOT 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 0035-3247-5294.