BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE HCG ASSAY

    MDR report key: 1163266 · Received September 15, 2008

    Report

    Report Number
    2017183-2008-00038
    Event Type
    Other
    Date Received
    September 15, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 30, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K990222
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DECLINED SERVICE AND DID NOT ALLOW A SIEMENS FIELD SERVICE ENGINEER (FSE) TO INVESTIGATE THE EVENT. ANALYSIS OF THE CUSTOMER EVENT REPORT SUSPECTED THAT USER ERROR IS THE CAUSE FOR DISCORDANT HCG RESULT. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A NEGATIVE IMMULITE HCG RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE ORIGINAL SAMPLE WAS RETESTED AND THE HCG RESULT WAS STILL NEGATIVE. A NEW SAMPLE WAS DRAWN AND THE IMMULITE HCG RESULT WAS POSITIVE. THE ORIGINAL PATIENT SAMPLE WAS RETESTED AT A DIFFERENT LAB AND THE HCG RESULTS WERE POSITIVE. PATIENT TREATMENT WAS NOT ALTERED AND 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 HCG ASSAY HCG IMMUNOASSAY DHA SIEMENS HEALTHCARE DIAGNOSTICS NA 330

    Patients

    Seq Age Sex Outcome Treatment
    1