BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 1000

    MDR report key: 3720121 · Received April 2, 2014

    Report

    Report Number
    2247117-2014-00017
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJQ
    PMA / PMN Number
    K022603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE AND EVALUATED THE IMMULITE 1000 INSTRUMENT. THE FSE DISCOVERED THAT THE BARCODE READER WAS NOT PERFORMING ACCORDING TO SPECIFICATIONS AND REPLACED THE BARCODE READER. THE CUSTOMER THEN TESTED THE SYSTEM WITH NO FURTHER PROBLEMS. THE CAUSE OF THE BARCODE LABEL NOT BEING READ ON THE IMMULITE 1000 INSTRUMENT WAS DUE TO A FAULTY BARCODE READER. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE BARCODE LABEL OF A TURBO INTACT PARATHYROID HORMONE (IPTH) KIT COULD NOT BE READ BY THE IMMULITE 1000 INSTRUMENT. THE CUSTOMER RAN THE KIT AT ANOTHER FACILITY ON AN IMMULITE 1000 INSTRUMENT AND THE BARCODE LABEL WAS READ BY THE INSTRUMENT. THE CUSTOMER INDICATED THAT SURGERY WAS DELAYED DUE TO THE BARCODE LABEL NOT BEING READ. THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE BARCODE LABEL NOT BEING READ ON THE IMMULITE 1000 INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199347 IMMULITE 1000 IMMULITE 1000 JJQ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 1000

    Patients

    Seq Age Sex Outcome Treatment
    1