BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS + USA

    MDR report key: 3857059 · Received June 9, 2014

    Report

    Report Number
    1217157-2014-00079
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 14, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ACCIDENTLY DISCARDED THE TEST TABLE INSERT WHERE THE HCG CARTRIDGE IS PLACED INTO THE INSTRUMENT. THE TEST TABLE INSERT WAS REPLACED AND PASSED QUALITY CONTROL ON LEVEL 1 AND 2. THE EVENT HAS OCCURED DUE TO AN OPERATOR ERROR.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED NEGATIVE HCG (HUMAN CHORIONIC GONADOTROPIN) ON THREE PATIENT RESULTS. FOR TWO OF THE THREE PATIENT, THE INSTRUMENT GAVE AN E68 ERROR (ERROR CODE 68 - INSUFFICIENT SAMPLE) AND HGC WAS NOT REPEATED WITH SECONDARY METHODS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335059 CLINITEK STATUS + USA CT STATUS + JIL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1