BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEK STATUS+

    MDR report key: 4223298 · Received November 4, 2014

    Report

    Report Number
    1217157-2014-00165
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 6, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K091216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAD BEEN REQUESTED TO PERFORM PRECISION STUDY BUT THEY DID NOT PROVIDE SPECIFIC RESULTS OF PRECISION SURVEY. CUSTOMER INDICATED THAT THE UNIT IS OPERATIONAL AND THEY HAVE NOT HAD ANY FURTHER ISSUES. CUSTOMER INDICATED THAT THEY WILL NOT BE PURSUING THIS ISSUE ANY FURTHER. THE CAUSE FOR THE DISCORDANT RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCORDANT RESULTS BETWEEN INSTRUMENT AND OTHER UNIT. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706483 CLINITEK STATUS+ CT STATUS+ JIL SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1