BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2060395 · Received April 15, 2011

    Report

    Report Number
    2122870-2011-01014
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE LI HEPARIN WITH GEL BARRIERS THAT ARE CENTRIFUGED FOR TWELVE (12) MINUTES AT 3400 RPM. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE ERRONEOUS RESULTS. LEVEL 1 QC PERFORMED ON (B)(4) 2011 WAS OUT OF RANGE HIGH. SYSTEM CHECKS PERFORMED ON (B)(4) 2011, BOTH MET SPECIFICATIONS. THE CUSTOMER RECALIBRATED AND REPEATED QC AND ALL THREE LEVELS OF QC WERE OUT OF SPECIFICATIONS HIGH. THE CUSTOMER RE-CALIBRATED USING A DIFFERENT REAGENT LOT AND A DIFFERENT CALIBRATOR LOT NUMBER AND QC RECOVERED WITHIN RANGE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI), IN REGARDS TO OBTAINING THYROID-STIMULATING HORMONE (TSH) RESULTS THAT DID NOT MEET ASSAY PRECISION CLAIMS ACROSS TWO (2) REAGENT LOTS FOR EIGHT (8) PATIENT SAMPLES THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH 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