BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2436074 · Received February 2, 2012

    Report

    Report Number
    2432235-2012-00018
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    September 26, 2011
    Report Date
    January 6, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CFP
    PMA / PMN Number
    K022603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMULITE 2000 INSULIN IMPRECISION IS UNKNOWN AT THIS TIME. THIS INCIDENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4) 2012 ADDITIONAL INFORMATION:THE IMMULITE 2000 INSULIN IMPRECISION ON LOT#308 HAS BEEN INVESTIGATED BY SIEMENS.SIEMENS HAS DETERMINED THAT THE CAUSE OF THE IMMULITE 2000 INSULIN IMPRECISION ON LOT# 308 IS DUE TO A REDUCTION IN THE CONCENTRATION 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.

    Description of Event or Problem · 1

    PATIENT SAMPLES WERE RUN IN DUPLICATE ON BOTH THE IMMULITE 2500XPI (USING INSULIN LOT# 193) AND THE IMMULITE 2000 (USING INSULIN LOT#308). RESULTS FROM BOTH SYSTEMS WERE COMPARED AND PRECISION ISSUES WITH IMMULITE 2000 INSULIN LOT#308 WERE OBSERVED. NO RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE INSULIN RESULTS.

    Description of Event or Problem · 1

    PATIENT SAMPLES WERE RUN IN DUPLICATE ON BOTH THE IMMULITE 2500XPI (USING INSULIN LOT# 193) AND THE IMMULITE 2000 (USING INSULIN LOT#308). RESULTS FROM BOTH SYSTEMS WERE COMPARED AND PRECISION ISSUES WITH IMMULITE 2000 INSULIN LOT#308 WERE OBSERVED. NO RESULTS WERE REPORTED TO THE PHYSICIAN.THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE INSULIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMULITE 2000 CFP SIEMENS HEALTHCARE DIAGNOSTICS, INC. IMMULITE 2000 INSULIN 308

    Patients

    Seq Age Sex Outcome Treatment
    1