BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 ACTH

    MDR report key: 6287868 · Received January 30, 2017

    Report

    Report Number
    2247117-2017-00010
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    October 26, 2016
    Report Date
    March 10, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    CKG
    PMA / PMN Number
    K960066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2247117-2017-00010 WAS FILED ON JANUARY 30, 2017. ADDITIONAL INFORMATION (02/13/2017): A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE DATA PROVIDED BY THE CUSTOMER AND STATED THAT THE DIFFERENCES BETWEEN THE RESULTS OBTAINED WHEN THE SAMPLE WAS RUN NEAT, DILUTED AND WHEN TREATED WITH NON-SPECIFIC ANTIBODY BLOCKING TUBE ARE INDICATIVE OF THE PRESENCE OF NON-SPECIFIC ANTIBODY INTERFERENCE. CORRECTED INFORMATION (02/13/2017): UPDATED WITH THE CORRECT PRODUCT INFORMATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER. THERE WAS NO INDICATION OF AN INSTRUMENT MALFUNCTION. THE CUSTOMER STATED THAT THE DISCORDANT RESULTS MAY HAVE BEEN DUE TO A SAMPLE SPECIFIC ISSUE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED ACTH RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED ADRENOCORTICOTROPIC HORMONE (ACTH) RESULT WAS OBTAINED ON ONE PATIENT UPON INITIAL TESTING ON AN IMMULITE 2000 XPI INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE PLATFORM, RESULTING LOWER. A SECOND TUBE WAS OBTAINED FROM THE PATIENT AND WAS TESTED NEAT AND WITH DILUTION (1:2 DILUTION FACTOR) ON THE IMMULITE 2000 XPI INSTRUMENT, RESULTING ELEVATED. SAMPLE FROM THE SECOND TUBE WAS THEN TESTED IN A TUBE TREATED WITH POLYETHYLENE GLYCOL (PEG), A NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT) AND A HETEROPHILIC BLOCKING TUBE (HBT) AND RUN ON THE IMMULITE 2000 XPI INSTRUMENT. NO RESULT WAS OBTAINED FROM THE PEG TUBE AS THE SAMPLE WAS VISCOUS. THE RESULTS FROM THE NABT AND HBT WERE STILL ELEVATED. THE CORRECTED RESULT OBTAINED ON THE ALTERNATE PLATFORM WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ACTH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69963 IMMULITE 2000 ACTH IMMULITE 2000 ACTH CKG SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 XPI 294

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR