BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 2030074 · Received March 25, 2011

    Report

    Report Number
    2122870-2011-00810
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND ON THE DAY OF THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2011 AND MET THE SPECIFICATIONS. SERVICE WAS ON SITE ON (B)(4) 2011, AND THE FIELD SERVICE ENGINEER (FSE) NOTED A LARGE AMOUNT OF BUBBLES FORMING IN THE WASH PUMP UPON INSPECTION OF THE FLUIDICS MODULE. THE FSE LOOKED FOR FLOW RESTRICTIONS WITHIN THE WASH PUMP LINES AND FOUND NONE. THE FSE CLEANED AND REASSEMBLED THE WASH PUMP, BUT BUBBLE FORMATION RE-OCCURRED. THE FSE REPLACED THE INTERIOR WASH PUMP PARTS AND THE BUBBLE FORMATION CEASED. SYSTEM CHECK PASSED INSTRUMENT SPECIFICATIONS AFTER SERVICING THE INSTRUMENT, AND QC WAS WITHIN THE ESTABLISHED RANGES. 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 ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS, ABOVE THE AMI CUTOFF AND WITHIN THE RISK STRATIFICATION RANGE, GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR THREE PATIENTS' SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED LOWER RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR EACH PATIENT. 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 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1