BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPASE FLEX(R) REAGENT CARTRIDGE

    MDR report key: 2041962 · Received April 6, 2011

    Report

    Report Number
    2517506-2011-00062
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 24, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CHI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED LIPASE RESULT IS USER ERROR. CUSTOMER REPORTED RESULT WITHOUT PROPER CALCULATION FOR DILUTION FACTOR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED LIPASE RESULT WAS OBTAINED ON A PATIENT. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE RESULT WAS IMMEDIATELY QUESTIONED WITHIN THE LAB AND REPEATED. A HIGHER RESULT WAS OBTAINED AND REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIPASE FLEX(R) REAGENT CARTRIDGE LIPASE FLEX(R) REAGENT CARTRIDGE CHI SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW BE1113

    Patients

    Seq Age Sex Outcome Treatment
    1