BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA 700

    MDR report key: 928988 · Received April 4, 2007

    Report

    Report Number
    1823260-2007-02721
    Event Type
    Malfunction
    Date Received
    April 4, 2007
    Date of Event
    March 19, 2007
    Report Date
    April 4, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    k951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT TWO PT SAMPLES GAVE DISCREPANT LGM RESULTS. THE FIRST SAMPLE GAVE A RESULT OF 77 MG/DL, WHICH REPEATED AS 5460 MG/DL. THE SECOND SAMPLE GAVE A RESULT OF 114 MG/DL, WHICH REPEATED AS 10640 MG/DL. NO TREATMENT WAS PROVIDED BASED ON THE INCORRECT RESULTS. THE FIELD SVC REP WAS UNABLE TO DETERMINE THE CAUSE FOR THE DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA 700 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA