BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 ERYTHROPOIETIN

    MDR report key: 2740509 · Received September 12, 2012

    Report

    Report Number
    2432235-2012-00310
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Date of Event
    August 6, 2012
    Report Date
    August 17, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GGT
    PMA / PMN Number
    K983203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE TECHNICAL SOLUTIONS CENTER (TSC) ABOUT THE DISCORDANT EPO RESULT. THE CUSTOMER STATED THAT THE LABORATORY HAS RUN DILUTIONS ON OTHER EPO SAMPLES AND OTHER ASSAYS THERE ARE NO PROBLEMS. BASED ON THIS, THE TSC SPECIALIST DETERMINED THAT THE INSTRUMENT DID NOT REQUIRE A FIELD SERVICE ENGINEER TO INSPECT. THE INSTRUCTIONS FOR USE (IFU) FOR THE EPO ASSAY ON THE IMMULITE 2000 INSTRUMENT DOES INDICATE THAT THE ASSAY HAS LIMITATIONS. THE IFU STATES: "HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH THE IMMUNOGLOBULINS INCLUDED IN THE ASSAY COMPONENTS CAUSING INTERFERENCE WITH IN VITRO IMMUNOASSAYS." THE CAUSE OF THE DISCORDANT EPO RESULT IS UNKNOWN.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED ERYTHROPOIETIN (EPO) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE IMMULITE 2000 INSTRUMENT WITH LOT # 230. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE LABORATORY REPORTED THAT THEY COULD NOT INTERPRET THE RESULT. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED EPO RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 ERYTHROPOIETIN ERYTHROPOIETIN ASSAY GGT SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 230

    Patients

    Seq Age Sex Outcome Treatment
    1