BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 IGF-1

    MDR report key: 2840857 · Received November 20, 2012

    Report

    Report Number
    2432235-2012-00390
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    August 10, 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
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE INCREASE IN ABNORMAL RESULTS FOR IGF-1 IS UNKNOWN. AN URGENT MEDICAL DEVICE CORRECTION (UMDC), UMDC 2012-11-13 - "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.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2012-00390 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.

    Description of Event or Problem · 1

    THE LABORATORY EVALUATED THEIR DATA FROM THE PAST THREE YEARS FOR INSULIN-LIKE GROWTH FACTOR (IGF-1) ON AN IMMULITE 2000 INSTRUMENT AND STATED THAT THERE HAD BEEN AN OVERALL POSITIVE SHIFT. THERE WAS A SHIFT OF APPROXIMATELY NINE PERCENT IN (B)(6) 2010 WHEN THE CUSTOMER BEGAN USING LOT 450. A SECOND SHIFT, OF APPROXIMATELY SEVEN PERCENT, OCCURRED IN (B)(6) 2011 WHEN THE CUSTOMER BEGAN USING LOT 470. 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 CFL SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 IGF-1 450; 470

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown