BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 INSULIN

    MDR report key: 2435600 · Received February 1, 2012

    Report

    Report Number
    2432235-2012-00028
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 5, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    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 510(K) NUMBER HAS BEEN CORRECTED: K022603.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) ABOUT THE DISCORDANT LOW INSULIN RESULTS WITH LOT 314. THE CAUSE OF THE DISCORDANT LOW INSULIN RESULTS IS UNKNOWN AT THIS TIME. THIS INCIDENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC) ABOUT THE DISCORDANT LOW INSULIN RESULTS WITH LOT 314. THE CAUSE OF THE DISCORDANT LOW INSULIN RESULTS IS UNKNOWN AT THIS TIME. THIS INCIDENT IS CURRENTLY UNDER INVESTIGATION. (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 THE CONCENTRATION OF THE INSULIN BEAD COAT ANTIBODY (RAW MATERIAL). THE DEVICE IS RUNNING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS NECESSARY.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON 02/01/2012. 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.

    Description of Event or Problem · 1

    DISCORDANT LOW INSULIN RESULTS WERE OBTAINED FOR PATIENT SAMPLES ON AN IMMULITE 2000 ANALYZER. THE CUSTOMER PERFORMED A CORRELATION STUDY WITH THEIR NEW LOT OF INSULIN REAGENT (LOT 314) AND THEIR PRIOR LOT OF INSULIN REAGENT (LOT 308). THE CUSTOMER REPORTED INCREASED IMPRECISION AND A NEGATIVE BIAS WITH INSULIN REAGENT LOT 314 (COMPARED TO LOT 308). THERE WERE NO KNOWN REPORTS OF PATIENT TREATMENT BEING ALTERED OR PRESCRIBED DUE TO THE DISCORDANT LOW INSULIN RESULTS. THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW INSULIN RESULTS.

    Description of Event or Problem · 1

    DISCORDANT LOW INSULIN RESULTS WERE OBTAINED FOR PATIENT SAMPLES ON AN IMMULITE 2000 ANALYZER. THE CUSTOMER PERFORMED A (B)(4) STUDY WITH THEIR NEW LOT OF INSULIN REAGENT (LOT 314) AND THEIR PRIOR LOT OF INSULILN REAGENT (LOT 308). THE CUSTOMER REPORTED INCREASED IMPRECISION AND A NEGATIVE BIAS WITH INSULIN REAGENT LOT 314 (COMPARED TO LOT 308). THERE WERE NO KNOWN REPORTS OF PATIENT TREATMENT BEING ALTERED OR PRESCRIBED DUE TO THE DISCORDANT LOW INSULIN RESULTS. THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW INSULIN RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1