BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS+ ANALYZER

    MDR report key: 2253184 · Received September 1, 2011

    Report

    Report Number
    1217157-2011-00030
    Event Type
    Other
    Date Received
    September 1, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 1, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.
    Product Code
    LCX
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE DID NOT APPEAR GROSSLY BLOODY OR TURBID. CALIBRATION BAR CLEANING TECHNIQUES WERE REVIEWED. MANUFACTURER UNABLE TO CONFIRM REAGENT LOT IS PROBLEMATIC. INSTRUMENT IS BEING RETURNED TO MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    HOSPITAL REPORTED A FALSE POSITIVE HCG ON A PEDIATRIC PATIENT. UNDETERMINED PROCEDURE OR TREATMENT WAS DELAYED PENDING GETTING THE NEGATIVE REPORT ON A SERUM HCG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINITEK STATUS+ ANALYZER CLINITEK STATUS+ ANALYZER LCX SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD. CT STATUS+

    Patients

    Seq Age Sex Outcome Treatment
    1