BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2782919 · Received August 23, 2005

    Report

    Report Number
    2122870-2005-00209
    Event Type
    Other
    Date Received
    August 23, 2005
    Date of Event
    July 25, 2005
    Report Date
    August 23, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY (POST EVENT): THE CUSTOMER INDICATED THAT QC WAS WITHIN THEIR SPECIFICATIONS PRIOR TO THE EVENT. SYSTEM CHECKS PERFORMED ON (B)(6) WERE WITHIN SPECIFICATIONS. THE SAMPLES WERE COLLECTED IN 13X100 BECTON DICKINSON SERUM SEPARATOR TUBES. THE SPECIMENS WERE CENTRIFUGED AT 4,000 RPM FOR 5 MINUTES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER LAB. THE FSE RAN SYSTEM CHECK, WHICH PASSED. THE FSE PERFORMED A DIAGNOSTIC TEST, WHICH PARTIALLY FAILED DUE TO ONE FLIER ON LUMWASHSON TEST. THE FSE REPLACED A WASH PUMP SEAL AND PERFORMED VOLUME CHECK; THE RESULTS WERE WITHIN SPECIFICATIONS. THE FSE REPLACED ALL ASPIRATE PROBES, TUBING AND A DISPENSE PROBE. THE FSE REPEATED DIAGNOSTIC TEST; ALL RESULTS WERE WITHIN SPECIFICATIONS. THE FSE VERIFIED THAT THE INSTRUMENT WAS PERFORMING PER ESTABLISHED PROCEDURES. ALTHOUGH THE FSE NOTED HARDWARE ISSUES, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULTS FROM FOUR (4) DIFFERENT PATIENTS THAT WERE GENERATED BY THE ACCESS INSTRUMENT. THE ELEVATED ACCU TNI RESULTS WERE: 0.78NG/ML, 0.98NG/ML, 1.21NG/ML, AND 1.29NG/ML FOR PATIENTS A TO D RESPECTIVELY. THE ACCU TNI RESULTS WERE NOT REPORTED OUT OF THE LAB. THE CUSTOMER INDICATED THAT THE PATIENTS¿ ORIGINAL SAMPLES WERE RE-TESTED FOR ACCU TNI. THE REPEAT ACCU TNI RESULTS WERE: 0.00NG/ML, 0.07NG/ML, 0.01NG/ML, AND 0.04NG/ML FOR PATIENTS A TO D RESPECTIVELY. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED. THE CUSTOMER INDICATED THAT THERE HAS BEEN NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other