THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS DGXN QUALITY CONTROL RESULT WAS OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. A VITROS INSTRUMENT ISSUE WAS THE MOST LIKELY ASSIGNABLE CAUSE FOR THE EVENT. AN ORTHO FIELD ENGINEER REPLACED SOME OF THE TUBING IN THE IMMUNO-RATE SUBSYSTEM ALONG WITH NECESSARY ADJUSTMENTS. POST SERVICE, THE QUALITY CONTROL RESULTS WERE BACK WITHIN EXPECTED RANGES, INDICATING THE VITROS SYSTEM WAS RETURNED TO ITS EXPECTED PERFORMANCE. BASED ON THE LIMITED NUMBER OF QC REPLICATES REVIEWED, AN ISSUE WITH VITROS DGXN REAGENT LOT 1913-0242-0362 CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTING FACTOR.
D
Patient 1
A CUSTOMER OBSERVED A LOWER THAN EXPECTED VITROS DGXN RESULT FROM A QUALITY CONTROL FLUID ON A VITROS 5600 INTEGRATED SYSTEM. VITROS TDM PERFORMANCE VERIFIER LEVEL III (LOT L5351) RESULT OF 1.94 NG/ML VS. THE EXPECTED RESULT OF 2.56 NG/ML NO PATIENT SAMPLES WERE IN QUESTION FOR VITROS DGXN 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. (B)(4).