BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 4775329 · Received May 15, 2015

    Report

    Report Number
    2247117-2015-00028
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 22, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LYR
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST. THE CUSTOMER STATED THAT THEY RECEIVED PROBE WASH ERRORS WHILE RUNNING THE PATIENT SAMPLES. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INSTRUMENT DATA AND STATED THAT THE DISCORDANT RESULTS WERE CONSISTENT WITH THE INSTRUMENT RUNNING OUT OF WATER. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE INSTRUMENT AND TESTED THE WASHING, THE PIPETTING AND THE READING MECHANISMS. THE CSE COULD NOT FIND ANY INSTRUMENT MALFUNCTION. THE CSE RAN QUALITY CONTROLS, WHICH WERE WITHIN THE ACCEPTABLE RANGES. THE CAUSE OF THE DISCORDANT, FALSE POSITIVE H. PYLORI IGG RESULTS ON TWO PATIENT SAMPLES IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSE POSITIVE H. PYLORI IGG RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 INSTRUMENT, RESULTING NEGATIVE. THE CORRECTED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE POSITIVE H. PYLORI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318932 IMMULITE 2000 IMMULITE 2000 LYR SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1