THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS DIGOXIN (DGXN) RESULTS WERE OBTAINED FROM A NON-VITROS MAS QUALITY CONTROL (QC) FLUID AND A VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUID PROCESSED USING VITROS DGXN SLIDES IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE AN ASSIGNABLE CAUSE. THE INITIAL UNEXPECTED RESULTS OF 1.77 ON (B)(6) 2018 AND 1.98 ON (B)(6) 2018 WERE BOTH RESOLVED BY RETESTING OF THE CONTROL FLUID. AFTER A LATER CALIBRATION EVENT, THE ISSUE RECURRED WITH MULTIPLE CALIBRATION EVENTS UNABLE TO RESOLVE IT. THIS INDICATES THE POSSIBILITIES OF IMPROPER FLUID HANDLING OR THE VITROS DGXN SLIDE LOT CONTRIBUTING TO THE EVENT. HOWEVER, A VITROS DGXN WITHIN-RUN PRECISION TEST WAS WITHIN THE ACCEPTABLE GUIDELINES INDICATING VITROS DGXN SLIDE LOT 1916-0251-2165 WAS PERFORMING AS INTENDED. THE ISSUE WAS LATER RESOLVED BY CALIBRATING WITH A DIFFERENT SET OF THE SAME LOT OF CALIBRATORS. THE VITROS 5600 INTEGRATED SYSTEM WAS PERFORMING AS INTENDED AND DID NOT LIKELY CONTRIBUTE TO THE EVENT AS WITHIN-RUN PRECISION PERFORMANCE WAS WITHIN ACCEPTABLE GUIDELINES. IN ADDITION, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT SHOW A POTENTIAL SYSTEMIC ISSUE WITH VITROS DGXN SLIDE LOT 1916-0251-2165.
D
Patient 1
A CUSTOMER REPORTED LOWER THAN EXPECTED QUALITY CONTROL (QC) RESULTS FROM BOTH A NON-VITROS MAS QC FLUID AND A VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) OBTAINED USING VITROS DIGOXIN (DGXN) SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. MAS LOT CHU1907A L3 RESULTS OF 1.77, 1.98 AND 1.80 NG/ML VS. THE EXPECTED RESULT OF 2.60 NG/ML. TDM PV III R5360 RESULT OF 1.62 NG/ML VS. THE EXPECTED RESULT OF 2.12 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE UNEXPECTED VITROS DGXN RESULTS WERE GENERATED FROM NON-PATIENT FLUIDS AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER 2 OF 4 MDR?S FOR THIS EVENT. FOUR (4) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 4 DEVICES WERE INVOLVED. (B)(4).