BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS+

    MDR report key: 3932336 · Received July 14, 2014

    Report

    Report Number
    1217157-2014-00101
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 20, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOTICS
    Product Code
    JIL
    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

    SIEMENS TECHNICAL OPERATION TEAM CHECKED THE INSTRUMENT AND FOUND A FULL STRIP INSIDE THE INSTRUMENT. THEY ALSO FOUND A PIECE OF TISSUE, A PIECE OF PAPER, AND A PAD STUCK TO THE INSTRUMENT CASE UNDER THE TABLE CENTER. THERE WERE ALSO SPLASH MARKS ALONG THE MIRROR. SIEMENS TECHNICAL OPERATION TEAM REMOVED ALL THE DEBRIS AND CLEANED THE MIRROR. SIEMENS TECHNICAL OPERATIONS TEAM PERFORMED ALL SERVICE TESTS ON THE INSTRUMENT AND IT PASSED ALL THE TESTS. THEY ALSO INDICATED SEVERAL HCG SAMPLES WERE RAN ON INSTRUMENT WITH NO ISSUE. FROM THE INVESTIGATION, IT WAS DETERMINED THAT ROOT CAUSE FOR THE FALSE NEGATIVE HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT IS DUE TO DEBRIS INSIDE OF THE INSTRUMENT AND SPLASH MARKS ON THE MIRROR. INSTRUMENT IS OPERATIONAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE HUMAN CHORIONIC GONADOTROPIN (HCG) RESULT ON THE INSTRUMENT. CUSTOMER INDICATED THAT PATIENT WAS VERY DISTRESSED. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411262 CLINITEK STATUS+ CT STATUS+ JIL SIEMENS HEALTHCARE DIAGNOTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 35