BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 IGF-1

    MDR report key: 2840833 · Received November 20, 2012

    Report

    Report Number
    2432235-2012-00392
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    July 31, 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

    THE INITIAL MDR 2432235-2012-00392 WAS FILED ON NOVEMBER 20, 2012.(B)(4): ADDITIONAL INFORMATION: 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. POSITIVE BIAS WAS NOTICED ON KIT LOT 480 IN COMPARISON TO KIT LOT 477. 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