BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ACTH

    MDR report key: 19471990 · Received June 5, 2024

    Report

    Report Number
    1823260-2024-01677
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    June 15, 2022
    Report Date
    August 7, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CKG
    UDI-DI
    04015630939893
    PMA / PMN Number
    K060585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE CUSTOMER NOTED THAT A HETEROPHILE ANTIBODY INTERFERENCE HAD BEEN RULED OUT. THE FIELD SERVICE REPRESENTATIVE CHECKED ALL PROBES, ADJUSTMENTS, PRESSURES, AND LEVELS. HE PERFORMED MECHANISM CHECKS AND INSTRUMENT CHECKS SUCCESSFULLY. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE CUSTOMER'S CALIBRATION SIGNALS WERE SLIGHTLY HIGHER THAN EXPECTED AND THE QC WAS ABOVE EXPECTED LEVELS. SAMPLE SHORT ALARMS WERE OBSERVED IN THE SYSTEM'S ALARM TRACE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    SECTION D4 LOT NUMBER WAS UPDATED. A REAGENT LOT NUMBER WAS PROVIDED FOR THE ALLEGED RESULTS THAT OCCURRED ON (B)(6) 2024.

    Description of Event or Problem · 0

    THERE IS A SUSPECTED INTERFERENCE WITH THE ELECSYS ACTH ASSAY DUE TO QUESTIONABLE RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. ON 15-JUN-2022 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 39480 PG/ML FOLLOWING A DILUTION. ON 15-SEP-2022 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 29000 PG/ML FOLLOWING A DILUTION. ON 10-MAR-2023 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 61050 PG/ML FOLLOWING A DILUTION. ON 28-JUL-2023 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 7375 PG/ML FOLLOWING A DILUTION. ON 16-JAN-2024 THE INITIAL RESULT WAS > 2000 PG/ML. THE REPEATED RESULT WAS 71850 PG/ML FOLLOWING A DILUTION. THE SAMPLE WAS TESTED USING THE SIEMENS IMMULITE METHOD WITH MULTIPLE DILUTIONS AND THE RESULTS WERE HIGH. THE NUMERIC RESULTS WERE NOT PROVIDED. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822742 ELECSYS ACTH ADRENOCORTICOTROPIC HORMONE (ACTH) TEST SYSTEM CKG ROCHE DIAGNOSTICS 750778 04015630939893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown