BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 INTACT PTH

    MDR report key: 540595 · Received March 17, 2004

    Report

    Report Number
    2017183-2004-00001
    Event Type
    Malfunction
    Date Received
    March 17, 2004
    Date of Event
    February 17, 2004
    Report Date
    March 16, 2004
    Manufacturer
    DIAGNOSTIC PRODUCTS CORP.
    Product Code
    JJQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HIGH BIAS OF APPROXIMATELY 30% WAS OBSERVED WITH IMMULITE 2000 INTACT PTH KIT LOTS L2KPP2,6 117 & 118 WHEN PT SAMPLES COLLECTED AS EDTA PLASMA WERE ANALYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 INTACT PTH INVITRO DIAGNOSTIC TEST KIT JJQ DIAGNOSTIC PRODUCTS CORP. NA 117

    Patients

    Seq Age Sex Outcome Treatment
    1 *