BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BN PROSPEC SYSTEM

    MDR report key: 10838477 · Received November 13, 2020

    Report

    Report Number
    9610806-2020-00059
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 16, 2020
    Report Date
    December 11, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2020-00059 ON 13-NOV-2020. ADDITIONAL INFORMATION (17-NOV-2020): SECTION B7 OF THE MDR WAS UPDATED WITH ADDITIONAL INFORMATION RECEIVED ON 17-NOV-2020. ADDITIONAL INFORMATION (18-NOV-2020): QUALITY CONTROLS (QC) RECOVERED IN RANGE AT THE TIME OF THE EVENT. THE PROVIDED CALIBRATION CURVE WAS ALSO INCONSPICUOUS. THE ISSUE WAS LIMITED TO ONE PATIENT SAMPLE. ADDITIONAL INFORMATION (10-DEC-2020): THE AFFECTED PATIENT SAMPLE WAS SENT TO SIEMENS FOR INVESTIGATION TESTING. THE SAMPLE WAS RERUN TWICE FOR ALBUMIN, GENERATING CORRECT RESULTS OF 483 MG/L AND 499 MG/L. NO SAMPLE ABNORMALITIES WERE OBSERVED VISUALLY. THE CAUSE OF THE EVENT IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW ALBUMIN RESULT WAS OBTAINED ON A PATIENT CEREBROSPINAL FLUID (CSF) SAMPLE ON A BN PROSPEC SYSTEM USING N ANTISERUM TO HUMAN ALBUMIN REAGENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S), AS IT DID NOT MATCH THE PATIENT'S TOTAL PROTEIN RESULT. THE SAME SAMPLE WAS REPEATED TWICE FOR ALBUMIN CSF, RECOVERING HIGHER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). TWO DAYS LATER, THE SAME SAMPLE WAS REPEATED AGAIN FOR ALBUMIN CSF, RECOVERING HIGHER AND CONFIRMING THE REPEAT RESULTS FROM TWO DAYS PRIOR. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ALBUMIN CSF RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305234 BN PROSPEC SYSTEM BN PROSPEC SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN PROSPEC SYSTEM 00630414002736

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR