THE INVESTIGATION DETERMINED THAT THE CUSTOMER OBTAINED HIGHER AND LOWER THAN EXPECTED VITROS LACTATE QUALITY CONTROL (QC) RESULTS USING THE VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS MOST LIKELY THE USE OF SUB-OPTIMAL CALIBRATIONS THAT SUBSEQUENTLY CAUSED THE HIGHER AND LOWER THAN EXPECTED LACTATE QUALITY CONTROL RESULTS. THE CUSTOMER OBTAINED MULTIPLE SUB-OPTIMAL CALIBRATION PARAMETERS WHEN COMPARED TO EXPECTED PARAMETERS USING THE SAME VITROS LACTATE LOT WITH THREE DIFFERENT CALIBRATOR KIT LOTS AND THEREFORE, IT IS NOT LIKELY THAT THE ISSUE WAS RELATED TO THE CALIBRATOR KIT LOTS THEMSELVES. IMPROPER PRE-ANALYTICAL CALIBRATOR FLUID HANDLING IS A LIKELY CONTRIBUTING FACTOR, BUT THIS COULD NOT BE DEFINITIVELY CONFIRMED. A SUCCESSFUL RECALIBRATION USING THE SAME LACTATE LOT WAS OBTAINED WITH NO CHANGES TO THE INSTRUMENT OR THE LACTATE REAGENT. A MALFUNCTION OF THE VITROS 5600 INTEGRATED SYSTEMS OR A VITROS LAC REAGENT LOT ISSUE ARE NOT LIKELY CONTRIBUTORS TO THIS EVENT.
D
Patient 1
A CUSTOMER OBTAINED HIGHER AND LOWER THAN EXPECTED VITROS LACTATE QUALITY CONTROL RESULTS WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. VITROS L1= 2.57, 2.58 VS. EXPECTED 1.34 MMOL/L; VITROS L2= 7.11, 7.11, 7.11, 7.18 VS. EXPECTED 3.84 MMOL/L; BIORAD L1= 4.84 VS. EXPECTED 5.86 MMOL/L. 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 LACTATE RESULTS WERE GENERATED FROM NON-PATIENT FLUIDS, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED AND WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT IS NUMBER THREE OF SEVEN MDR?FOR THIS EVENT. SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVEN DEVICES WERE INVOLVED. (B)(4).