BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1932273 · Received December 17, 2010

    Report

    Report Number
    2122870-2010-00904
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    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 13X100 PLASTIC GREINER SERUM TUBE WITH A GEL SEPARATOR. THE CUSTOMER STATED TO CUSTOMER TECHNICAL SUPPORT (CTS) THAT THE TUBE WAS PROPERLY MIXED BY INVERSION AND ALLOWED TO CLOT FOR 30 MINUTES PRIOR TO CENTRIFUGATION. CENTRIFUGE INFORMATION IS NOT AVAILABLE. THE INITIAL AND THE FIRST REPEAT RESULTS WERE OBTAINED FROM THE PRIMARY TUBE. THE SECOND REPEAT WAS OBTAINED FROM AN ALIQUOT IN A 2ML SAMPLE CUP. ALL THREE LEVELS OF TSH QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR AND POST THE EVENT. ON (B)(6) 2010 THE CUSTOMER PERFORMED ROUTINE SYSTEM CHECK, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED ROUTINE SYSTEM CHECK, A HIGH SENSITIVITY SYSTEM AND 20 REPLICATE TSH PRECISION TEST; ALL TESTS PASSED WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS. FSE DID NOT NOTE ANY HARDWARE ISSUES. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS ELEVATED TSH RESULT FOR ONE PATIENT GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER THE ORIGINAL SAMPLE WAS REPEATED ON THE SAME UNIT AND LOWER RESULT 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