BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 IGF-1

    MDR report key: 2864186 · Received December 10, 2012

    Report

    Report Number
    2432235-2012-00424
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    September 13, 2012
    Report Date
    November 9, 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
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE INCREASE IN ABNORMAL RESULTS FOR IGF-1 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. NEW DATE OF AWARENESS: DURING A LOOKBACK OF PMDRS RELATED TO THE IGF-1 BIAS FIELD CORRECTION, THIS COMPLAINT WAS IDENTIFIEDAS BELONGING TO THE ISSUE ADDRESSED IN THE FIELD CORRECTION. ON 11/09/2012, THE DECISION TO ISSUE A UFSN (UFSN 4005) WAS MADE DUE TO A POSITIVE SHIFT IN PATIENT MEDIANS OF APPROXIMATELY 20% WHICH OCCURRED BETWEEN LATE 2009 AND MID 2011. THE PERFORMANCE OF THE KIT LOTS CURRENTLY IN DISTRIBUTION IS IN ALIGNMENT WITH THE REFERENCE RANGE DATA PUBLISHED IN THE INSTRUCTIONS FOR USE (IFU).

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2012-00424 WAS FILED ON (B)(4) 2012. (B)(4) 2012: ADDITIONAL INFORMATION: THE CORRECTIONS AND REMOVAL REPORT (CRR) WAS FILED WITH THE FDA ON (B)(6) 2012. THE CRR NUMBER IS 2432235-11/28/2012-007-C.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THEY HAVE OBSERVED POSITIVE BIAS WITH THE INSULIN-LIKE GROWTH FACTOR (IGF-1) ASSAY ON KIT LOTS 486 AND 487. 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-1 486; 487

    Patients

    Seq Age Sex Outcome Treatment
    1