BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000 ACTH

    MDR report key: 6041815 · Received October 19, 2016

    Report

    Report Number
    2432235-2016-00636
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    July 22, 2016
    Report Date
    October 20, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED
    Product Code
    CKG
    PMA / PMN Number
    K960066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2016-00636 WAS FILED ON OCTOBER 19, 2016. CORRECTED INFORMATION (10/20/2016): SECTION OF THE INITIAL MDR STATES THAT MODEL # IS IMMULITE 2000 PSA. THE CORRECT MODEL # IS IMMULITE 2000 ACTH. SECTION HAS BEEN UPDATED WITH THIS INFORMATION.

    Additional Manufacturer Narrative · 1

    A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE DATA PROVIDED BY THE CUSTOMER. THE HSC SPECIALIST INDICATED THAT ACTH ASSAY MEASURES INTACT ACTH BY USING ANTIBODIES DIRECTED AGAINST THE C AND N TERMINAL PEPTIDE SEQUENCES. THE CROSS-REACTIVITY BETWEEN THE INTERMEDIATE PEPTIDES IS NOT EXPECTED. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED ACTH RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED ADRENOCORTICOTROPIC HORMONE (ACTH) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHEN USING REAGENT KIT 291. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND WAS TESTED ON AN ALTERNATE SITE WHERE IT WAS RUN ON ANOTHER IMMULITE 2000 INSTRUMENT, ALSO RESULTING ELEVATED. THE PATIENT ALSO HAD PREVIOUS ACTH TESTING PERFORMED ON AN UNKNOWN PLATFORM ON (B)(6) 2016 AND BOTH THE RESULTS WERE ELEVATED. THE PATIENT HAD UNDERGONE IMAGIOLOGY EXAMINATION DUE TO THE DISCORDANT RESULTS AND THE IMAGIOLOGY EXAMINATION RESULTS WERE NORMAL. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED DUE TO THE NORMAL IMAGIOLOGY RESULTS. IT IS UNKNOWN IF THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ACTH RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690741 IMMULITE 2000 ACTH IMMULITE 2000 ACTH CKG SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 ACTH 291

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR