BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HE4 ASSAY

    MDR report key: 22459119 · Received July 9, 2025

    Report

    Report Number
    1823260-2025-02095
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 12, 2025
    Report Date
    July 25, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    OIU
    PMA / PMN Number
    K112624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE E602 MODULE SERIAL NUMBER WAS (B)(6).

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE. TWO "ABNORMAL SAMPLE ASPIRATION" ALARMS WERE OBSERVED ON THE ALARM TRACE DATA FROM THE DAY OF THE EVENT. THESE ALARMS SUGGEST POSSIBLE SAMPLE HANDLING ISSUES. THE LAST INSTRUMENT MAINTENANCE RECORD WAS FROM 24-APR-2025. NO ISSUES WERE IDENTIFIED WITH THE MEASURING CELL COUNTS. THE CUSTOMER DID NOT USE RACK ADAPTERS WITH 13 MM SAMPLE TUBES. PER PRODUCT LABELING, A "CUP ADAPTER IS MANDATORY FOR E602" ANALYZERS FOR TUBES WITH A DIAMETER EQUAL TO OR LESS THAN 13 MM." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HE4 (HE4) ON A COBAS E 602 MODULE. THE INITIAL RESULT WAS > 1500 PMOL/L. THE REPEAT RESULT WAS 73.96 PMOL/L. THE INITIAL RESULT DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL DIAGNOSIS AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924008 ELECSYS HE4 ASSAY EPITHELIAL OVARIAN TUMOR ASSOCIATED ANTIGEN (HE4) TEST OIU ROCHE DIAGNOSTICS 82301101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown