BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS+

    MDR report key: 9214371 · Received October 21, 2019

    Report

    Report Number
    3002637618-2019-00112
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    September 25, 2019
    Report Date
    December 9, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JHI
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: CHANGED PRODUCT CODE - PRODUCT CODE FROM JIL TO JHI (USED FOR HCG). SIEMENS SERVICE REPORT: ALL TESTS WERE PERFORMED USING THE POWER SUPPLY THAT CAME IN WITH THE INSTRUMENT AND THE INSTRUMENT WAS CONNECTED TO ITS CONNECT PLATFORM WITH THE BARCODE READER PLUGGED IN. WHEN SERVICE UNPACKED THE TABLE ASSEMBLY, THEY NOTICED A MARK ON THE CALIBRATION BAR WHICH LOOKED LIKE DRY SPILLAGE. ON CLOSER INSPECTION WHEN THE MARKS WOULD NOT CLEAN OFF, THEY FOUND THAT THE MARKS WERE PHYSICAL DAMAGE TO THE BAR. THE TABLE ASSEMBLY WAS REPLACED AND TEN CASSETTES WERE RUN WITH NO FALSE RESULTS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT REPEAT TESTING WAS PERFORMED TO CONFIRM CORRECT RESULTS WHICH MET THE CLINICAL PICTURE AND A CORRECTED REPORT WAS ISSUED. THE INSTRUMENT HAS BEEN REQUESTED FOR RETURN TO THE WORKSHOP FOR INVESTIGATION. PROPER TECHNIQUE AND MAINTENANCE WERE REVIEWED WITH THE CUSTOMER. THERE WERE NO ISSUES FOUND. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CLINITEK STATUS+ WAS GENERATING BORDERLINE HCG RESULTS ON NEGATIVE SAMPLES. ONE PATIENT'S PROCEDURE (UNKNOWN) WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007088 CLINITEK STATUS+ CLINITEK STATUS+ JHI SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1