BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BN PROSPEC SYSTEM

    MDR report key: 9922652 · Received April 3, 2020

    Report

    Report Number
    9610806-2020-00012
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    March 5, 2020
    Report Date
    April 3, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    UDI-DI
    00630414002736
    PMA / PMN Number
    K001647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS (QC) RECOVERED WITHIN RANGE AT THE TIME OF THE EVENT. ALL DISCORDANT, FALSELY DEPRESSED SAMPLE RESULTS WERE FLAGGED WITH A Y FLAG. AS PER THE BN PROSPEC INSTRUCTION MANUAL, RESULTS WITH A Y FLAG CAN ONLY BE RELEASED IF A SUFFICIENT SAMPLE VOLUME IS ASSURED AND THE RESULT RECOVERS WITHIN THE MEASURING RANGE. ALL DISCORDANT, FALSELY DEPRESSED RESULTS RECOVERED BELOW THE INITIAL MEASURING RANGE. THEREFORE, THE REPORTING OF THE DISCORDANT, FALSELY DEPRESSED FLC TYPE KAPPA AND FLC TYPE LAMBDA RESULTS CAN BE ATTRIBUTED TO USE ERROR. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FIVE DISCORDANT, FALSELY DEPRESSED FREE LIGHT CHAINS (FLC) TYPE KAPPA RESULTS AND FOUR DISCORDANT, FALSELY DEPRESSED FLC TYPE LAMBDA RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A BN PROSPEC SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). FOUR DAYS LATER, THE SAMPLES WERE RERUN FOR FLC TYPE KAPPA AND FLC TYPE LAMBDA ON THE SAME BN PROSPEC SYSTEM, RESULTING HIGHER. THESE RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FIVE DISCORDANT, FALSELY DEPRESSED FLC TYPE KAPPA RESULTS AND FOUR DISCORDANT, FALSELY DEPRESSED FLC TYPE LAMBDA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389090 BN PROSPEC SYSTEM BN PROSPEC SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN PROSPEC SYSTEM 00630414002736

    Patients

    Seq Age Sex Outcome Treatment
    1