BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2012522 · Received March 10, 2011

    Report

    Report Number
    2122870-2011-00594
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TSH SAMPLE WAS COLLECTED IN A LIHEP PLASMA TUBE WHICH WAS CENTRIFUGED FOR FIVE MINUTES AT 3700 RPM AT ROOM TEMPERATURE. QC CHARTS, ALL THREE LEVELS OF TSH QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. ON (B)(6) 2011, THE CUSTOMER PERFORMED ROUTINE SYSTEM CHECK, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. ON (B)(6) 2011, A SECOND ROUTINE SYSTEM CHECK FAILED SPECIFICATIONS. PER CUSTOMER'S EVENT LOG, NO ERRORS MESSAGES WERE POSTED DURING THE TIMEFRAME OF THE RESULT IN THE PRESENTATION TABLE ABOVE. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED: PREVENTIVE MAINTENANCE ON THE INSTRUMENT. HIGH SENSITIVITY SYSTEM CHECK, NO ISSUES WERE NOTED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS ELEVATED THYROID STIMULATING HORMONE (TSH) RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER THE ORIGINAL SAMPLE WAS REPEATED ON ALTERNATE UNIT AND LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE WAS OBTAINED. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO 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. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1