BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2920738 · Received January 17, 2013

    Report

    Report Number
    2247117-2013-00008
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 19, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED IGF-1 RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2247117-2013-00008 WAS FILED ON (B)(4) 2013. 01/30/2013: ADDITIONAL INFORMATION: A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED THAT THE SAMPLE PROBE ALIGNMENT REQUIRED ADJUSTMENT, WHICH WAS THEN DONE. THE FSE ALSO DISCOVERED THAT THE WATER SUPPLY HAD BEEN EMPTY WHILE THE SAMPLES WERE IN PROGRESS, PREVENTING ADEQUATE WASHING. THE FSE RAN PRECISION, WHICH RESULTED WELL. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED IGF-1 RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED INSULIN-LIKE GROWTH FACTOR (IGF-1) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE FIRST SAMPLE WAS RERUN IN DUPLICATE AND THE SECOND SAMPLE WAS RERUN ONCE, AND THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED IGF-1 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26620 IMMULITE 2000 IMMULITE 2000 JJE SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1