BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 IGF-1

    MDR report key: 2840794 · Received November 20, 2012

    Report

    Report Number
    2432235-2012-00386
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    August 21, 2012
    Report Date
    October 22, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CFL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2432235-11/28/2012-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012: THE CORRECTIONS AND REMOVAL REPORT (CRR) WAS FILED WITH THE FDA ON NOVEMBER 28, 2012. THE CRR NUMBER IS 2432235-11/28/2012-007-C.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE FALSELY ELEVATED IGF-1 RESULTS IS UNKNOWN. AN URGENT FIELD SAFETY NOTICE (UFSN), UFSN 4005 - "IMMULITE / IMMULITE 1000 / IMMULITE 2000 / IMMULITE 2000 XPI ALL IMMULITE PLATFORMS FOR IGF-I SHIFT IN PATIENT MEDIANS AND SUPPLY DISRUPTION" WAS SENT TO CUSTOMERS IN NOVEMBER 2012. SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    A POSITIVE BIAS HAS BEEN OBSERVED IN PATIENT RESULTS FOR INSULIN-LIKE GROWTH FACTOR (IGF-1) OBTAINED ON AN IMMULITE 2000 XPI INSTRUMENT. A PATHOLOGIST QUESTIONED THE HIGH IGF-1 VALUES AFTER REVIEWING ALL PATIENT RESULTS FROM 2008 TO 2012. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IGF-1 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IGF-1 IMMULITE 2000 XPI CFL SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 IGF-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown