BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 3613630 · Received February 7, 2014

    Report

    Report Number
    2517506-2014-00038
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    December 8, 2013
    Report Date
    January 10, 2014
    Manufacturer
    INPECO S.P.A.
    Product Code
    CEM
    PMA / PMN Number
    510(K)EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2517506-2014-00038 WAS FILED WITH THE FDA ON FEBRUARY 07, 2014. THE FIRST SUPPLEMENTAL MDR 2517506-2014-00038_S1 WAS FILED WITH THE FDA ON APRIL 25, 2014. CORRECTED DATA: SECTION OF THE INITIAL MDR AND OF THE FIRST SUPPLEMENTAL MDR CONTAINED THE INCORRECT NAME AND ADDRESS OF THE MANUFACTURER. THESE SECTIONS HAVE BEEN UPDATED WITH THE CORRECTED INFORMATION. THE FIRST SUPPLEMENTAL MDR STATES THAT THE DEVICE MANUFACTURER IS (B)(4). THE CORRECT NAME FOR THE DEVICE MANUFACTURER IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2517506-2014-00038 WAS FILED ON FEBRUARY 7, 2014. ADDITIONAL INFORMATION (04/24/2014): THE ASSAY AND MATERIAL TYPE WERE PROVIDED BY THE CUSTOMER. THE CUSTOMER CONFIGURED THE NEMO SOFTWARE ON THE FLEXLAB SYSTEM. THE CAUSE OF THE PATIENT SAMPLES BEING RUN WITH THE INCORRECT MATERIAL AND INSTRUMENT CODES WAS MISCONFIGURATION BY THE CUSTOMER. (B)(4)

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE INCORRECT MATERIAL AND INSTRUMENT CODES BEING CONFIGURED IN THE FLEXLAB SOFTWARE SYSTEM IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    THE OPERATOR OF A FLEXLAB SYSTEM STATED THAT THREE PATIENT SAMPLES BEING TESTED FOR IMMUNOGLOBULIN G (IGG) HAD BEEN RUN WITH THE INCORRECT MATERIAL AND INSTRUMENT CODES. THE IGG METHOD HAD BEEN INSTALLED ON NEMO, THE FLEXLAB SOFTWARE SYSTEM, AND IT WAS LATER DISCOVERED THAT THE MATERIAL CODE WAS INCORRECTLY SET TO 'PLASMA' AND THE INSTRUMENT CODE WAS INCORRECTLY SET TO 0910 INSTEAD OF 0922. IT IS UNKNOWN WHAT ASSAY THE IGG WAS FOR OR IF THERE WERE ANY DISCORDANT RESULTS. IT IS UNKNOWN IF RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE THREE IGG SAMPLES BEING RUN WITH INCORRECT MATERIAL AND INSTRUMENT CODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79792 FLEXLAB CLINICAL CHEMISTRY ANALYZER CEM INPECO S.P.A. FLEXLAB

    Patients

    Seq Age Sex Outcome Treatment
    1