BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 XPI

    MDR report key: 9461050 · Received December 12, 2019

    Report

    Report Number
    2247117-2019-00104
    Event Type
    Malfunction
    Date Received
    December 12, 2019
    Date of Event
    September 26, 2019
    Report Date
    December 12, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414945422
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER (CCC) AND A CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED. CSE INSPECTED THE INSTRUMENT AND NOTICED AIR BUBBLES IN DUAL RESOLUTION DILUTOR (DRD) SYRINGES AND ORDERED NEW SYRINGE SEALS. CUSTOMER RAN PRECISION TESTING WITH A NEW PACK OF CALCITONIN REAGENT. CSE REPLACED UPPER AND LOWER SEALS IN BOTH SAMPLE AND REAGENT DRD SYRINGES. THE CAUSE OF THE EVENT WAS DUE TO SYRINGE SEALS MALFUNCTION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT CALCITONIN PATIENT RESULTS WERE REPORTED USING AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. SID 0242962 WAS AUTO-DILUTED AND REPEATED ON THE SAME INSTRUMENT. SID 1463172 HAD RECOLLECTED SAMPLES AND WAS REPEAT TWICE ON THE SAME INSTRUMENT. PATIENT WITH SID 1463172 ALSO HAD A CATSCAN PERFORMED AS A RESULT OF THE INITIAL DISCORDANT RESULT. THE REPEATED RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256175 IMMULITE 2000 XPI IMMULITE 2000 XPI JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 XPI 00630414945422

    Patients

    Seq Age Sex Outcome Treatment
    1