BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BN PROSPEC® SYSTEM

    MDR report key: 6065631 · Received October 29, 2016

    Report

    Report Number
    2517506-2016-00396
    Event Type
    Malfunction
    Date Received
    October 29, 2016
    Date of Event
    September 26, 2016
    Report Date
    November 21, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JZW
    PMA / PMN Number
    K001647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL MDR (2517506-2016-00396) WAS FILED ON 10/29/2016. CORRECTED INFORMATION (10/31/2016): SECTIONS MANUFACTURER NAME, CITY AND STATE AND MANUFACTURING SITE ADDRESS/PHONE FOR DEVICES WERE UPDATED WITH THE CORRECT MANUFACTURER NAME AND ADDRESS. A CORRECTED MDR WAS SUBMITTED UNDER THE APPROPRIATE MANUFACTURER REPORT NUMBER. THE CORRECT MANUFACTURER REPORT NUMBER SHOULD HAVE BEEN 9610806-2016-00036.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCREPANT FLC RESULTS IS AN INSTRUMENT MALFUNCTION OF THE DILUENT PUMP. THE CUSTOMER RUNS IGG SUBCLASSES WITH A SIEMENS REAGENT AND MEASURES FREE LIGHT CHAIN (FLC) KAPPA AND LAMBDA WITH THE NON-SIEMENS BINDING SITE REAGENT ON THE BN PROSPEC. THE SIEMENS IGG SUBCLASSES REAGENTS WERE SHOWING QC RESULTS OUT OF LABORATORY RANGES BUT SOME OF THE FLC QC WAS WITHIN LABORATORY LIMITS. NO INSTRUMENT ERRORS WERE LOGGED. THE CUSTOMER WENT AHEAD AND RAN ALL FLC PATIENTS AND RELEASED THE RESULTS TO THE DOCTOR WHILE THE ANALYSER WAS FAILING THE DILUENT PUMP CALIBRATION. AS NO ERROR WAS DISPLAYED, THE OPERATOR CONTINUED RUNNING THE ANALYSER REPORTING OUT INCORRECT RESULTS FOR THE BINDING SITE FLC KAPPA AND LAMBDA. A FIELD ENGINEER REPLACED THE DILUENT PUMP AND RETURNED THE INSTRUMENT TO SERVICE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCREPANT FREE LIGHT CHAIN (FLC) RESULTS (KAPPA AND LAMBDA) WERE OBTAINED ON PATIENT SAMPLES WITH THE BINDING SITE FLC REAGENT ON THE BN PROSPEC INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. AFTER AN INSTRUMENT MALFUNCTION WAS IDENTIFIED AND REPAIRED, THE SAME SAMPLES WERE REPEATED AND CORRECTED RESULTS WERE ISSUED. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE DISCREPANT FLC KAPPA AND LAMBDA RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCREPANT FLC KAPPA AND LAMBDA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716719 BN PROSPEC® SYSTEM BN PROSPEC® SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN PROSPEC

    Patients

    Seq Age Sex Outcome Treatment
    1