BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1963106 · Received January 18, 2011

    Report

    Report Number
    2122870-2011-00065
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 20, 2010
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A PLASTIC LITHIUM HEPARIN PLASMA TUBE WITH A GEL SEPARATOR, AND WAS CENTRIFUGED AT 4500 RPM FOR 5 MINUTES AT ROOM TEMPERATURE. QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND ON THE DAY OF THE EVENT. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(4) 2010 AND THE RESULTS WERE WITHIN THE INSTRUMENT SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER ONLY WANTED TO REPORT THE ISSUE. 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 AN ERRONEOUSLY ELEVATED THYROID STIMULATING HORMONE (HTSH) RESULT GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON THE ORIGINAL AND AN ALTERNATE INSTRUMENT PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1