BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS+ ANALYZER

    MDR report key: 2240591 · Received August 25, 2011

    Report

    Report Number
    1217157-2011-00031
    Event Type
    Other
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS MFG., LTD.
    Product Code
    LCX
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REQUESTED INSTRUMENT FOR EVAL. INITIAL TEST BY MFR WAS A FALSE POSITIVE RESULT. INSTRUMENT INSPECTED AND DEBRIS OBSERVED ON OPTIC'S MIRROR. MIRROR CLEANED AND MULTIPLE REPEAT TESTING RESULTS WERE NORMAL. NO FURTHER PROBLEMS WERE REPORTED WITH THE INSTRUMENT.

    Description of Event or Problem · 1

    PT WAS TESTED FOR HCG AS PRE-OPERATION PROCEDURE. PT SAMPLE WAS TESTED 4 TIMES. RESULTS ALTERNATED BETWEEN POSITIVE AND NEGATIVE. NO UNNECESSARY MEDICAL PROCEDURE WAS PERFORMED. NO TREATMENT WAS WITHHELD AS A RESULT OF THIS INCIDENT. THERE WAS NI IMPACT TO PT HEALTH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1