D
Patient 1
CUSTOMER CALLED ON (B)(6) 2012 REPORTING OF FALSE POSITIVE RHEUMATOID FACTOR (RF) RESULTS WHICH WERE GENERATED OVER A PERIOD OF A FEW DAYS ON THEIR IMMAGE 800 IMMUNOCHEMISTRY SYSTEM BUT NOT REPORTED OUTSIDE THE LAB. CUSTOMER STATED THAT SHE WAS SEEING AN INCREASE IN THE NUMBER OF FALSE POSITIVE RF PATIENT RESULTS WHEN USING RF REAGENT LOT # M103174. CUSTOMER STATED THAT MORE THAN 10% OF THE PATIENTS WERE RECOVERING ABOVE 20 IU/ML AND ON REPEAT THE RESULTS WERE LESS THAN 20 IU/ML. CUSTOMER INDICATED THAT THE CONTROLS WERE IN RANGE BEFORE AND AFTER THE INCIDENT. CUSTOMER REPORTED THAT THEY WERE USING RF REAGENT LOT # M103174, CAL-5 PLUS LOT # M101436, BUFF-2 LOT # M010306 AND DIL-1 LOT # T010145. CUSTOMER ALSO INDICATED THAT RECALIBRATING RF WITH THE SAME LOT# OF REAGENT DID NOT RESOLVE THE ISSUE. CUSTOMER HAD REQUESTED A REPLACEMENT CAL-5 PLUS LOT NUMBER AND WAS SENT A NEW LOT # M106396. UPON REVIEW OF THE INSTRUMENT PRINTOUTS PROVIDED BY THE CUSTOMER, IT WAS NOTED THAT THE ERRONEOUS RESULTS WERE GENERATED ON THREE DIFFERENT DAYS FOR FOUR DIFFERENT PATIENTS. THIS REPORT IS FOR THE ERRONEOUS RESULT WHICH WAS GENERATED ON (B)(6) 2011. PLEASE SEE MEDWATCH #2050012-2012-00227 AND #2050012-2012-00259 FOR THE REPORT ON THE OTHER THREE PATIENTS. CUSTOMER PRINTOUTS INDICATED THAT ON (B)(6) 2011, AN ERRONEOUS PATIENT RESULT OF 20.8 IU/ML WAS GENERATED. UPON RERUN ON THE SAME INSTRUMENT ON 01/03/2012, A RESULT OF