BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 HCG ASSAY

    MDR report key: 2894584 · Received November 6, 2008

    Report

    Report Number
    2017183-2008-00044
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A NEGATIVE IMMULITE 2000 HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE AND BECAUSE THE RESULT WAS NOT CONSISTENT WITH THE PATIENT'S CONDITION (SHE IS PREGNANT), THE PHYSICIAN REQUESTED THE SAMPLE BE RETESTED. THE RETEST RESULTS FOR HCH WAS POSITIVE. PATIENT TREATMENT WAS NOT ALTERED OF PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HCG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 HCG ASSAY HCG IMMUNOASSAY DHA SIEMENS HEALTHCARE DIAGNOSTICS NA 229

    Patients

    Seq Age Sex Outcome Treatment
    1