BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 581056 · Received March 10, 2005

    Report

    Report Number
    2122870-2005-00028
    Event Type
    Other
    Date Received
    March 10, 2005
    Date of Event
    February 3, 2005
    Report Date
    March 10, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DPZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER DPZ BECKMAN COULTER, INC. ACCESS 2 IMMUNASSAY SYSTEM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other