BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ACTH

    MDR report key: 22741820 · Received August 7, 2025

    Report

    Report Number
    1823260-2025-02417
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 1, 2025
    Report Date
    November 17, 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

    THE COBAS E 602 MODULE SERIAL NUMBER IS (B)(6). THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INCLUDED A REVIEW OF THE QC DATA. THE QC RESULTS WERE WITHIN THE SPECIFIED RANGES. TWO SAMPLES (THE REPORTED MORNING AND A RECOLLECTED AFTERNOON SAMPLE) FROM THE PATIENT WERE RECEIVED FOR INVESTIGATION. THE INVESTIGATION NOTED THAT THE RECOLLECTED PATIENT SAMPLE WAS HEMOLYTIC. THE INVESTIGATION TESTED THE PATIENT SAMPLES FOR ELECSYS ACTH ASSAY; THE INVESTIGATION CONFIRMED THE CUSTOMER'S RESULTS. THE INVESTIGATION ALSO SENT THE PATIENT SAMPLES TO AN EXTERNAL LABORATORY THAT USES A SIEMENS ANALYZER; THE RESULTS FROM THE EXTERNAL LABORATORY MATCHED THE ELECSYS ACTH ASSAY RESULTS. PRODUCT LABELING STATES, "SPECIMEN COLLECTION AND PREPARATION - ONLY USE PRE-COOLED SAMPLING VIALS. AFTER DRAWING THE BLOOD, PUT THE VIALS IMMEDIATELY ON ICE. USE A COOLED CENTRIFUGE TO SEPARATE THE PLASMA. MEASURE SAMPLES IMMEDIATELY OR FREEZE THEM AT -20 °C (± 5 °C). STABLE FOR 3 HOURS AT 2-8 °C FOLLOWED BY 2 HOURS AT 20-25 °C, 10 WEEKS AT -20 °C (± 5 °C). FREEZE ONLY ONCE." THE INVESTIGATION DID NOT IDENTIFY A REAGENT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THAT THEY WOULD OBTAIN QUESTIONABLE ELECSYS ACTH ASSAY RESULTS FROM PATIENT SAMPLES TESTED ON THE COBAS E 602 MODULE ABOUT ONCE A MONTH. ONE EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED: THE INITIAL RESULT OF THE INITIAL PATIENT SAMPLE WAS 523.8 PG/ML. THE RESULT OF A NEW SAMPLE WAS 51.92 PG/ML. THE REPORTER DEEMED THE INITIAL RESULT TOO HIGH AND THE RESULT DISCREPANCY TOO LARGE, REGARDLESS OF ACTH'S DIURNAL VARIATION, RELATION TO STRESS OR OTHER FACTORS. THE REPORTER STATED THAT THE EXPECTED "MEASUREMENT" WAS ABOUT 30 PG/ML. THE DATE OF EVENT IS UNKNOWN AND ONLY A TENTATIVE DATE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388936 ELECSYS ACTH ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM CKG ROCHE DIAGNOSTICS 812719

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PREDNISONE-TRANSITIONING FROM 20 TO 2.5 MG/DAY.