THE INVESTIGATION CONCLUDED THAT LOWER THAN EXPECTED VITROS CHEMISTRY PRODUCTS DGXN RESULTS WERE ATTAINED FROM NON-VITROS QUALITY CONTROL (QC) FLUIDS USING VITROS DGXN SLIDES IN COMBINATION WITH A VITROS 5,1 FS CHEMISTRY SYSTEM. AN ASSIGNABLE CAUSE FOR THE EVENT COULD NOT BE DETERMINED. AFTER THE CUSTOMER PERFORMED A SECONDARY CALIBRATION EVENT USING VITROS DGXN LOT 1916-0251-2567 ON (B)(6) 2018 THE QC RESULTS WERE ACCEPTABLE. ALTHOUGH IT IS UNKNOWN IF THE CUSTOMER PERFORMED MAINTENANCE ACTIVITIES, THE PRECISION AFTER THIS CALIBRATION EVENT IMPROVED SUGGESTING POSSIBLE ACTION BY THE CUSTOMER PRIOR TO THE CALIBRATION EVENT MAY HAVE MITIGATED A POSSIBLE UNKNOWN ANALYZER RELATED ISSUE. THEREFORE, AN ANALYZER RELATED ISSUE CANNOT BE RULED OUT NOR CONFIRMED AS THE CAUSE OF THE EVENT. BECAUSE THE CALIBRATION PARAMETERS FOR BOTH THE ORIGINAL CALIBRATION EVENT AND (B)(6) 2018 CALIBRATION EVENT WERE SIMILAR, A SUBOPTIMAL CALIBRATION IS NOT A LIKELY CAUSE OF THE LOWER THAN EXPECTED RESULTS. FURTHERMORE, THE IMPROVED PERFORMANCE USING THE SAME REAGENT INDICATES THE VITROS DGXN REAGENT LOT 1916-0251-2567 DID NOT CONTRIBUTE TO THE EVENT. THE CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1916-0251-2567.
D
Patient 1
A CUSTOMER REPORTED LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS FROM NON-VITROS QUALITY CONTROL (QC) FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES IN COMBINATION WITH A VITROS 5,1 FS CHEMISTRY SYSTEM. NON-VITROS QC FLUID BIORAD LEVEL 2 VITROS DGXN RESULTS OF 1.97, 1.92, 1.90, 1.90, 1.91, 1.75, 1.94, 1.99, 1.60, 1.64, 1.93, 1.75, 1.84 AND 1.67 MG/DL VERSUS THE EXPECTED VITROS DGXN RESULT OF 3.22 MG/DL. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER THAN EXPECTED VITROS DGXN RESULTS WERE OBTAINED WHEN PROCESSING QUALITY CONTROL FLUIDS. HOWEVER, IT CANNOT BE CONCLUDED THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER 9 OF 14 MDR?S FOR THIS EVENT. FOURTEEN (14) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 14 DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).