BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2120757 · Received June 10, 2011

    Report

    Report Number
    2122870-2011-01794
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLES WERE COLLECTED IN LIHEP BD VACCUTAINER SERUM TUBES WITH NO GEL AND WERE CENTRIFUGED FOR 10 MINUTES AT 3500 RPM IN A SWINGING BUCKET CENTRIFUGE. THE SAMPLES WERE TRANSFERRED INTO INSERT CUPS PRIOR TO BEING ANALYZED ON THE ACCESS 2. PER THE CUSTOMER SUPPLIED DATA, QC IS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES. PRIOR TO THE EVENT, SYSTEM CHECK DATA SUPPLIED BY THE CUSTOMER PASSED WITHIN INSTRUMENT SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND CHECKED ALIGNMENTS AND ULTRASONICS UPON ARRIVAL TO THE CUSTOMER SITE. THE FSE THEN PRIMED THE SYSTEM AND COMPLETED A PASSING SYSTEM CHECK WITHIN INSTRUMENT SPECIFICATIONS. THE FSE PERFORMED QC WITHIN THE CUSTOMER'S ESTABLISHED RANGES TO VERIFY HARDWARE. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING DISCORDANT TROPONIN (ACCUTNI) RESULTS ABOVE THE AMI CUTOFF FOR ONE (1) PATIENT THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT RESULTS FROM THE INSTRUMENT ARE DISCORDANT TO TWO ADDITIONAL METHODS THE CUSTOMER USED TO PERFORM PATIENT TESTING. THE SAMPLES WERE NOT REPEATED ON THE ORIGINAL INSTRUMENT BECAUSE THE TWO ADDITIONAL METHOD RESULTS CONFIRMED THE ELEVATED RESULTS WERE ERRONEOUS TO THE CUSTOMER. THE CUSTOMER SENT A PATIENT SAMPLE INTO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER INVESTIGATIONAL TESTING AND INTERFERENCE TESTING. RESULTS OF THE CPLS TESTING ARE NOT AVAILABLE TO DATE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR