VITROS CHEMISTRY PRODUCTS GLU SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED GLUCOSE RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLUCOSE (GLU) SLIDES LOT 0027-3245-2918 ON A VITROS 250 CHEMISTRY SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS GLU LOT 0027-3245-2918 PERFORMANCE ISSUE IS NOT LIKELY A CONTRIBUTOR TO THE EVENT. ALTHOUGH SLIGHT IMPRECISION WAS OBSERVED IN THE PERFORMANCE VERIFIER FLUID THAT RUNS AT A HIGHER CONCENTRATION, THE MAGNITUDE OF BIAS OBSERVED IS NOT EQUIVALENT TO THE BIAS OBSERVED IN THE PATIENT SAMPLE RESULT. THE RESULTS OF VITROS GLU PRECISION TESTING PERFORMED ON THE VITROS 250 CHEMISTRY SYSTEM WAS WITHIN ORTHO ACCEPTABLE GUIDELINES, INDICATING THAT VITROS GLU LOT 0027-3245-2918 WAS PERFORMING AS EXPECTED IN COMBINATION WITH THE VITROS 250 SYSTEM. ALTHOUGH THE CUSTOMER DID NOT PROCESS A DIAGNOSTIC PRECISION TEST, THERE IS NO EVIDENCE OF A SYSTEM MALFUNCTION. PER THE VITROS GLU INSTRUCTIONS FOR USE (IFU), UNOPENED VITROS GLU REAGENT THAT WILL BE USED WITH SODIUM FLUORIDE SAMPLE TYPES CAN BE STORED REFRIGERATED FOR: 4 MONTHS. THE CUSTOMER CONFIRMED THAT THEY FIRST RECEIVED VITROS GLU LOT 0027-3245-2918 ON (B)(6) 2025 AND HAVE BEEN STORING THEM IN THE REFRIGERATOR SINCE THEN. THE CUSTOMER IS NOT FOLLOWING THE VITROS GLU IFU AND IT IS POSSIBLE THAT THE IMPROPER REAGENT STORAGE FOR THE SAMPLE TYPE THAT IS IN USE CONTRIBUTED TO THE LOWER-THAN-EXPECTED RESULT. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS THE CUSTOMER WAS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURER 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 0027-3245-2918.

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 RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS GLUCOSE (GLU) SLIDES LOT 0027-3245-2918 ON A VITROS 250 CHEMISTRY SYSTEM. PATIENT SAMPLE RESULT OF 25 MG/DL VS AN EXPECTED RESULT OF 176 MG/DL 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 REPORTED FROM THE LABORATORY AND QUESTIONED BY A PHYSICIAN. NO TREATMENT WAS INITIATED, ALTERED OR STOPPED BASED ON THE RESULT AND A CORRECTED REPORT WAS LATER ISSUED. 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).