BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BN PROSPEC SYSTEM

    MDR report key: 12252028 · Received July 30, 2021

    Report

    Report Number
    9610806-2021-00053
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    June 29, 2021
    Report Date
    July 30, 2021
    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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS (QC) RECOVERED IN RANGE AT THE TIME OF THE EVENT. THE ISSUE WAS LIMITED TO THE INITIAL SAMPLE DETERMINATION FOR FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) FOR ONE PATIENT SAMPLE. THERE ARE NO REPORTS OF OTHER SAMPLES AFFECTED. THE CAUSE OF THE EVENT IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW FREE LIGHT CHAINS, TYPE LAMBDA (FLC LAMBDA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN PROSPEC SYSTEM USING N LATEX FLC LAMBDA REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE ELECTROPHORESIS FOR THE AFFECTED SAMPLE SHOWED A HIGHER RESULT, SO THE SAMPLE WAS RERUN TWO TIMES FOR FLC LAMBDA ON THE BN PROSPEC SYSTEM THREE DAYS LATER, ONCE USING A 1:100 AND ONCE USING A 1:400 DILUTION, RECOVERING HIGHER. THE RESULT OBTAINED USING THE 1:400 DILUTION WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THREE DAYS LATER, THE SAMPLE WAS RERUN FOUR MORE TIMES FOR FLC LAMBDA ON AN ATELLICA NEPH 630 SYSTEM, ONCE USING 1:20 DILUTION, ONCE USING A 1:100 DILUTION, AND TWICE USING A 1:400 DILUTION, ALSO RECOVERING HIGHER AND MATCHING THE HIGHER REPEAT RESULT OBTAINED ON THE BN PROSPEC SYSTEM. A NEW SAMPLE FROM THE SAME PATIENT WAS RUN THREE TIMES FOR FLC LAMBDA ON THE ATELLICA NEPH 630 SYSTEM, ONCE USING 1:20 DILUTION, ONCE USING A 1:100 DILUTION, AND ONCE USING A 1:400 DILUTION, MATCHING THE HIGHER RESULTS FROM THE PREVIOUS SAMPLE. NONE OF THE RESULTS FROM THE ATELLICA NEPH 630 SYSTEM WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW FLC LAMBDA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152706 BN PROSPEC SYSTEM BN PROSPEC SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN PROSPEC SYSTEM 00630414002736

    Patients

    Seq Age Sex Outcome Treatment
    1