BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ACTH

    MDR report key: 17791014 · Received September 21, 2023

    Report

    Report Number
    1823260-2023-03056
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 14, 2023
    Report Date
    October 16, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CKG
    PMA / PMN Number
    K060585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. SAMPLE TYPE AND SAMPLE STABILITY ISSUES COULD NOT BE EXCLUDED. THE SAMPLES WERE REPEATEDLY FROZEN WHICH IS ALLOWED ONLY ONCE PER PRODUCT LABELING AND BEYOND THE STABILITY PER DOCUMENTED IN PRODUCT LABELING WHEN TESTED FOR THE PRELIMINARY INVESTIGATION. CALIBRATION AND QC DATA DO NOT SUGGEST ANY REAGENT ISSUE.

    Additional Manufacturer Narrative · 0

    G1 CONTACT OFFICE-MANUFACTURING SITE WAS UPDATED.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS 8000 CORE ANALYZER WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ACTH ELECSYS E2G RESULTS FROM THE COBAS 8000 CORE ANALYZER. THE RESULTS FROM THE CUSTOMER OVER TIME AFTER LOADING FOR ACTH: 0 MINUTES (SAMPLE 1): 100 PG/ML. 15 MINUTES (SAMPLE-2): 113 PG/ML. 30 MINUTES (SAMPLE-3): 110 PG/ML. ON 7-SEP-2023, THE PRELIMINARY INVESTIGATION TESTED THE SAMPLES ON A COBAS E801 MODULE: SAMPLE 1: 53.0 PG/ML. SAMPLE 2: 71.7 PG/ML. SAMPLE 3: 65.6 PG/ML. BASED ON THE RESULTS, THE CUSTOMER SUSPECTED A NON-SPECIFIC REACTION IN ROCHE ASSAY. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446817 ELECSYS ACTH ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM CKG ROCHE DIAGNOSTICS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female