BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 ERYTHROPOIETIN

    MDR report key: 2764760 · Received September 28, 2012

    Report

    Report Number
    2432235-2012-00322
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 31, 2012
    Report Date
    August 31, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    GGT
    PMA / PMN Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS NOT DISPATCHED TO THE CUSTOMER SITE BECAUSE THE CUSTOMER DECLINED SERVICE. BASED UPON THE RESULTS, THE CUSTOMER STATED THAT THEY BELIEVED THE ISSUE WAS SAMPLE SPECIFIC. THE CAUSE OF THE DISCORDANT EPO RESULTS IS UNKNOWN. SIEMENS HAS REQUESTED THE SAMPLE FOR FURTHER TESTING.

    Description of Event or Problem · 1

    DISCORDANT ERYTHROPOIETIN (EPO) RESULTS WERE OBTAINED ON 2 SAMPLES FROM THE SAME PATIENT ON THE IMMULITE 2000 XPI INSTRUMENT, WHERE DILUTED RESULTS DID NOT MATCH THE NEAT VALUES. THE INITIAL RESULT (NEAT) WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT AND REQUESTED A DILUTION. THE CUSTOMER PERFORMED ONE MANUAL DILUTION FOLLOWED BY SERIAL DILUTIONS, AND THEN OBTAINED A SECOND SAMPLE TUBE FROM THE PATIENT AND REPEATED THE SAME PROCESS USING A DIFFERENT REAGENT LOT. THE CUSTOMER DID NOT REPORT OUT ANY OF THE RERUN RESULTS, AND STATED THAT THEY WOULD DISCUSS THE RESULTS WITH THE PHYSICIAN TO DETERMINE IF THE SAMPLE SHOULD BE SENT TO AN ALTERNATE LABORATORY. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT EPO RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 ERYTHROPOIETIN IMMULITE 2000 XPI GGT SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000 XPI 318 & 319

    Patients

    Seq Age Sex Outcome Treatment
    1