BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS ANALYZER

    MDR report key: 1719461 · Received June 8, 2010

    Report

    Report Number
    1217157-2010-00009
    Event Type
    Other
    Date Received
    June 8, 2010
    Date of Event
    May 24, 2010
    Report Date
    May 24, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
    Product Code
    LCX
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTS THAT QC WAS DONE PER INSTRUCTIONS OF OPERATOR GUIDE. CUSTOMER ACKNOWLEDGED THAT THE REASON FOR FALSE (+) WAS BECAUSE THE FIRST PT WAS TAKING FERTILITY DRUGS AND THE SECOND PT'S URINE WAS BLOODY. PER SIEMENS CUSTOMER BULLETIN, TAKING FERTILITY DRUGS CAN CAUSE HCG LEVELS BETWEEN 5-25 MIU/ML IN NON-PREGNANT WOMEN. WE ALSO DO NOT RECOMMEND RUNNING A BLOODY SAMPLE USING THE HCG CASSETTE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A FALSE POSITIVE CT HCG RESULT ON TWO PATIENTS. PT #1 WAS REPORTEDLY TAKING FERTILITY DRUGS AT THE TIME OF TESTING. DUE TO THE POSITIVE RESULT OBTAINED, A SURGICAL PROCEDURE SCHEDULED FOR THE PT WAS CANCELED. PT #2 WAS REPORTED AS A BLOODY SAMPLE. PT WAS RETESTED AND RESULT WAS NEGATIVE. FALSE POSITIVE WAS ATTRIBUTED TO BLOODY SAMPLE. THERE WAS NO HARM CAUSED TO EITHER PT AS A RESULT OF THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITEK STATUS ANALYZER CLINITEK STATUS ANALYZER LCX SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1