A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS GENT QUALITY CONTROL RESULTS ON A VITROS 5600 INTEGRATED SYSTEM. VALUES OF 5.44, 3.83, 4.70, AND 4.41 UG/ML WERE OBTAINED FROM THE BIORAD LEVEL 2 FLUID VERSUS THE EXPECTED VALUE OR 7.83 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. NO PATIENT SAMPLES WERE RUN FOR VITROS GENT DURING THE TIME FRAME OF THIS EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDR'S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. (B)(4).
N
Patient 1
THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS GENT QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE CUSTOMER DEPLETED THEIR INVENTORY OF VITROS GENT LOT 1512-07-1075, THEREFORE, NO ADDITIONAL PERFORMANCE TESTS WERE COMPLETED USING THE AFFECTED REAGENT LOT. OCD HAS RECEIVED NO RELATED CUSTOMER COMPLAINTS FOR VITROS GENT LOT 1512-07-1075 TO SUGGEST A REAGENT ISSUE. AN ALTERNATE LOT OF VITROS GENT REAGENT GENERATED ACCEPTABLE QUALITY CONTROL PERFORMANCE. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE VITROS GENT REAGENT COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THAT AN ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.