BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINITEK STATUS ANALYZER

    MDR report key: 2062756 · Received April 7, 2011

    Report

    Report Number
    1217157-2011-00007
    Event Type
    Other
    Date Received
    April 7, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 15, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING LTD.
    Product Code
    LCX
    PMA / PMN Number
    K031947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COULD NOT CONFIRM WHETHER THE CONTROL, TEST OR REFERENCE LINES ON THE TEST CASSETTE WERE VISIBLY DEVELOPED. CUSTOMER DID NOT KNOW WHEN CALIBRATION BAR HAD LAST BEEN CLEANED. CONTROLS WERE LAST RUN BETWEEN (B)(6). CUSTOMER WAS ADVISED TO CLEAN CALIBRATION BAR AND RUN CONTROLS ON THE INSTRUMENT. BOTH LEVELS OF CONTROL PASSED AFTER CLEANING.

    Description of Event or Problem · 1

    PT WAS ADMITTED DUE TO PELVIC PAIN. CUSTOMER REPORTED A FALSE POSITIVE URINE HCG WHICH WAS CONFIRMED WITH SERUM BETA HCG. PT TREATMENT WAS DELAYED UNTIL FALSE POSITIVE CONFIRMED. NO UNNECESSARY MEDICAL PROCEDURE WAS PERFORMED. NO TREATMENT WAS WITHHELD AS A RESULT OF THIS INCIDENT. THERE WAS NO 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, MANUFACTURING LTD. CT STATUS

    Patients

    Seq Age Sex Outcome Treatment
    1