BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BN PROSPEC

    MDR report key: 6266559 · Received January 20, 2017

    Report

    Report Number
    9610806-2017-00006
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Date of Event
    December 21, 2016
    Report Date
    January 20, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    PMA / PMN Number
    K001647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT DEPRESSED IMMUNOGLOBULIN G, IMMUNOGLOBULIN A, AND IMMUNOGLOBULIN M (IGG, IGA AND IGM) RESULTS IS UNKNOWN. THE PATTERN OF LOW RESULTS ON MULTIPLE ANALYTES ON THE SAME SAMPLE IS SUGGESTIVE OF A PRE-ANALYTICAL SAMPLE ISSUE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT DEPRESSED IMMUNOGLOBULIN G, IMMUNOGLOBULIN A, AND IMMUNOGLOBULIN M (IGG, IGA AND IGM) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE BN PROSPEC INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS LATER REPEATED ON THE SAME INSTRUMENT AND HIGHER RESULTS WERE OBTAINED AND REPORTED. THE INITIAL DEPRESSED RESULTS WERE REGARDED AS DISCORDANT. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE DISCORDANT DEPRESSED IGG, IGA AND IGM RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT DEPRESSED IGG, IGA AND IGM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50671 BN PROSPEC BN PROSPEC NEPHELOMETER/PC/SOFTWARE KIT JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1