BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N ANTISERUM TO HUMAN ALBUMIN

    MDR report key: 8587818 · Received May 7, 2019

    Report

    Report Number
    9610806-2019-00048
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 8, 2019
    Report Date
    May 7, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    DCF
    PMA / PMN Number
    K972929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT A DISCORDANT, FALSELY ELEVATED ALBUMIN/CSF RESULT WAS OBTAINED ON A PATIENT SAMPLE USING N ANTISERUM TO HUMAN ALBUMIN LOT 153936E ON A BN PROSPEC SYSTEM (SERIAL NUMBER: 123196). SIEMENS ANALYZED THE SUBMITTED DATA FILE. THE CAUSE OF THE DISCORDANT RESULT COULD NOT BE DETERMINED. NO OTHER PATIENT SAMPLES OR QUALITY CONTROLS (QC) WERE REPORTED TO BE DISCORDANT BY THE CUSTOMER. SAMPLE INTEGRITY OR PRE-ANALYTICAL ISSUES COULD NOT BE RULED OUT. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED ALBUMIN/CEREBROSPINAL FLUID (CSF) RESULT WAS OBTAINED USING N ANTISERUM TO HUMAN ALBUMIN LOT 153936E ON THE BN PROSPEC SYSTEM (SERIAL NUMBER: (B)(4)). ALBUMIN WAS USED FOR CALCULATING THE CSF/ALBUMIN SERUM RATIO. THE INITIAL FALSELY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE INITIAL SAMPLE WAS REPEATED USING THE SAME INSTRUMENT AND REAGENT, RESULTING IN A LOWER VALUE. A SECOND REPEAT WAS PERFORMED TO CONFIRM THE LOWER RESULT AND IT ALSO RESULTED LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ALBUMIN/CSF RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379995 N ANTISERUM TO HUMAN ALBUMIN N ANTISERUM TO HUMAN ALBUMIN DCF SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N ANTISERUM TO HUMAN ALBUMIN 153936E

    Patients

    Seq Age Sex Outcome Treatment
    1