BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ACTH

    MDR report key: 15094293 · Received July 25, 2022

    Report

    Report Number
    1823260-2022-02180
    Event Type
    Malfunction
    Date Received
    July 25, 2022
    Date of Event
    June 1, 2022
    Report Date
    July 25, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CKG
    UDI-DI
    04015630939893
    PMA / PMN Number
    K060585
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. AS THIS WAS CONSIDERED AN ISOLATED INSTANCE OF NON-REPRODUCIBLE RESULTS, A GENERAL REAGENT PROBLEM COULD BE EXCLUDED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ACTH ELECSYS E2G RESULTS FROM A COBAS E 801 MODULE. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE SAMPLE FROM (B)(6) 2022 WAS SENT FOR INVESTIGATION AND TESTED ON A COBAS E 801 MODULE AND A COBAS E 602 MODULE. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR PATIENT DATA. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY TO THE PHYSICIAN. THE CUSTOMER BELIEVED THE RESULTS FROM (B)(6) 2021 AND (B)(6) 2022 WERE INCORRECT BUT BELIEVED THE RESULTS FROM (B)(6) 2022 WERE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1667737 ELECSYS ACTH ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM CKG ROCHE DIAGNOSTICS ACTH ASKU 04015630939893

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown