ACCESS 2 IMMUNOASSAY SYSTEM

Description of Event or Problem

CONTACTED REGARDING 3 ERRONEOUSLY ELEVATED TROPONIN (ACCU TRL) RESULTS FROM 3 DIFFERENT PTS (A, B AND C) THAT WERE GENERATED BY THE ACCESS 2 INSTRUMENT. PT A HAD AN ELEVATED ACCU. TNL RESULT OF 3.68NG/ML FROM SAMPLE #1 (PLASMA SAMPLE, PRIMARY TUBE). LATER ON THAT DAY, A NEW SERUM SAMPLE (#2) WAS COLLECTED FROM PT A FOR ACCU TNL. THE ACCU TNL RESULT FROM SAMPLE #2 WAS 0.16NG/ML. PT B HAD AN ELEVATED ACCU TNL RESULT OF 0.8NG/ML (PLASMA SAMPLE, PRIMARY TUBE). THE SAMPLE WAS POURED INTO A SAMPLE CUP AND RETESTED FOR ACCU TNL. THE REPEATED ACCU TNL RESULT WAS 0.02NG/ML. PT C HAD AN ELEVATED ACCU TNL RESULT OF 2.51NG/ML (PLASMA SAMPLE, PRIMARY TUBE). THE SAMPLE WAS POURED INTO A SAMPLE CUP AND RETESTED FOR ACCU TNL. THE REPEATED ACCU TNL RESULT WAS 0.21NG/ML. IT IS UNK IF ANY OF THE ELEVATED ACCU TNL RESULT WERE REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFO REGARDING THIS EVENT. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT THAT CAN BE ATTRIBUTED TO THIS EVENT.