N
Patient 1
THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS LAC RESULTS WERE OBTAINED FROM PROFICIENCY SAMPLES AND NON-VITROS QUALITY CONTROL FLUIDS WHEN USING VITROS CHEMISTRY PRODUCTS LAC REAGENT IN COMBINATION WITH A VITROS 5,1FS CHEMISTRY SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE FOR THE LOWER THAN EXPECTED RESULTS IS THE USE OF A SUB-OPTIMAL CALIBRATION EVENT. IT IS LIKELY THAT USER ERROR IN THE PREPARATION OF CALIBRATOR FLUIDS GENERATED THE SUBOPTIMAL CALIBRATION EVENT THAT LEAD TO THE LOWER THAN EXPECTED RESULTS. FOLLOWING RECALIBRATION, AN OPTIMAL CALIBRATION CURVE WAS OBTAINED AND THERE WERE NO ADDITIONAL LOWER THAN EXPECTED RESULTS OBSERVED. THERE IS NO EVIDENCE THAT WOULD INDICATE A VITROS LAC REAGENT LOT ISSUE OR A VITROS 5,1FS SYSTEM TRANSIENT MALFUNCTION
D
Patient 1
A CUSTOMER OBTAINED LOWER THAN EXPECTED LAC RESULTS FROM PROFICIENCY SAMPLES AND NON-VITROS QUALITY CONTROL FLUIDS RESULTS USING VITROS CHEMISTRY PRODUCTS LAC REAGENT LOT IN COMBINATION WITH A VITROS 5,1FS CHEMISTRY SYSTEM. THE FOLLOWING RESULTS BREACHED VITROS LAC POTENTIAL HEALTH AND SAFETY CRITERIA: VITROS LAC RESULT 3.3 VERSUS EXPECTED RESULT 4.81 MMOL/L, VITROS LAC RESULT 6.3 VERSUS EXPECTED RESULT 7.8 MMOL/L, VITROS LAC RESULT 2.4 VERSUS EXPECTED RESULT 3.71 MMOL/L, VITROS LAC RESULT 6.4 VERSUS EXPECTED RESULT 7.81 MMOL/L, VITROS LAC RESULT 2.8 VERSUS EXPECTED RESULT 4.35 MMOL/L. BIORAD L2 VITROS LAC RESULTS: 2.02, 2.06, 2.01, 2.06, 2.05, 2.03, 2.02, 2.11, 2.10, 2.10, 1.66, 2.05, 2.12, 2.11, 2.14, 2.09, 2.12, 2.08, 2.08, 2.07, 2.08, AND 2.08 MMOL/L VERSUS EXPECTED 3.49 MMOL/L. BIORAD L3 VITROS LAC RESULTS: 3.76, 3.81, 3.75, 4.03, 3.94, 3.87, 3.84, 3.76, 3.86, 3.89, 3.96, 3.90, 3.85, 3.82, 3.85, 3.84, AND 3.88 MMOL/L VERSUS EXPECTED 5.63 MMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE CUSTOMER STATED THAT NO PATIENT SAMPLES WERE IN QUESTION FOR VITROS LAC OVER THE TIME FRAME OF THE EVENT. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO (B)(4).