BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2424697 · Received January 23, 2012

    Report

    Report Number
    2432235-2012-00017
    Event Type
    Malfunction
    Date Received
    January 23, 2012
    Date of Event
    December 30, 2011
    Report Date
    December 30, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CFP
    PMA / PMN Number
    K022603
    Removal / Correction Number
    UR005-2012-04-26
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE IMMULITE INSULIN IMPRECISION IS UNKNOWN AT THIS TIME. THIS INCIDENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON 01/23/2012. SIEMENS HEALTHCARE DX HAS IMPLEMENTED A FIELD CORRECTION (URGENT DEVICE RECALL UR005-2012-04-26, APRIL 2012) FOR THE IMMULITE 2000/2000 XPI INSULIN ASSAY LOTS 312-316.

    Additional Manufacturer Narrative · 1

    (B)(4) 2012 ADDITIONAL INFORMATION:THE IMMULITE 2000 INSULIN IMPRECISION ON LOT#314 HAS BEEN INVESTIGATED BY SIEMENS.SIEMENS HAS DETERMINED THAT THE CAUSE OF THE IMMULITE 2000 INSULIN IMPRECISION ON LOT# 314 IS DUE TO A REDUCTION IN THECONCENTRATION OF THE INSULIN BEAD COAT ANTIBODY (RAW MATERIAL).SIEMENS BECAME AWARE OF THE ADDITIONAL INFORMATION ON 03/28/2012.THE DEVICE IS RUNING WITHIN SPECIFICATION.NO FURTHER EVALUATION OF THE DEVICE IS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE 510(K) NUMBER HAS BEEN CORRECTED: K022603.

    Description of Event or Problem · 1

    PRECISION ISSUES WITH IMMULITE 2000 INSULIN LOT#314 WERE OBSERVED BY THE CUSTOMER DURING LOT TO LOT VALIDATION AND CALIBRATION. NO PATIENT SAMPLES WERE TESTED, THEREFORE THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION.

    Description of Event or Problem · 1

    PRECISION ISSUES WITH IMMULITE 2000 INSULIN LOT#314 WERE OBSERVED BY THE CUSTOMER DURING LOT TO LOT VALIDATION AND CALIBRATION.NO PATIENT SAMPLES WERE TESTED, THEREFORE THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMULITE 2000 CFP SIEMENS HEALTHCARE DIAGNOSTICS, INC. IMMULITE 2000 INSULIN 314

    Patients

    Seq Age Sex Outcome Treatment
    1