BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BN PROSPEC SYSTEM

    MDR report key: 17539626 · Received August 14, 2023

    Report

    Report Number
    9610806-2023-00011
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    July 20, 2023
    Report Date
    August 14, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT A FALSELY DEPRESSED N LATEX CYSTATIN C (N CYSC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN PROSPEC SYSTEM. QUALITY CONTROL AND CALIBRATION WERE ACCEPTABLE ON THE DAY OF EVENT. THE CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. DURING THE VISIT, THE CSE OBSERVED THAT THE PROBE WAS MISPOSITIONED. THE CSE CORRECTED THE PROBE ALIGNMENT. THEN, THE CSE RAN QUALITY CONTROLS, WHICH RECOVERED WITHIN ACCEPTABLE RANGES. SIEMENS EVALUATED THE INSTRUMENT DATA AND DETERMINED THAT THERE WERE NO HARDWARE ERRORS GENERATED BY THE INSTRUMENT. THE CAUSE OF THE FALSELY DEPRESSED N CYSC RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    A FALSELY DEPRESSED N LATEX CYSTATIN C (N CYSC) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN PROSPEC SYSTEM. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. ON THE FOLLOWING DAY, THE SAMPLE WAS REPROCESSED ON THE ORIGINAL INSTRUMENT TWICE. THE REPEAT RESULTS WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO A FALSELY DEPRESSED N CYSC RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084104 BN PROSPEC SYSTEM BN PROSPEC SYSTEM JZW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BN PROSPEC SYSTEM 00630414002736

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown