BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HE4

    MDR report key: 18367603 · Received December 20, 2023

    Report

    Report Number
    1823260-2023-04145
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    December 6, 2023
    Report Date
    February 28, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    OIU
    UDI-DI
    04015630929641
    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 SAMPLE WAS SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S HE4 RESULTS WERE REPRODUCED ON AN E601 MODULE (278 PMOL/L). DILUTION AND SPIKING EXPERIMENTS WERE PERFORMED AND THE SAMPLE UNDERWENT HETEROPHILIC BLOCKING TUBE (HBT) TREATMENT; THE RESULTS RECEIVED DID NOT INDICATE THE PRESENCE OF AN INTERFERING SUBSTANCE. THE SAMPLE UNDERWENT POLYETHYLENE GLYCOL (PEG) TREATMENT; THE RESULTS SUGGEST THE PRESENCE OF AN INTERFERING SUBSTANCE, HOWEVER, THE RESULTS GENERATED DO NOT EXPLAIN THE DIFFERENCE IN RESULTS BETWEEN THE ROCHE METHOD AND THE ABBOTT METHOD. FURTHER CLARIFICATION OF THE ROOT CAUSE FOR THE DIFFERENCES BETWEEN THE ROCHE AND ABBOTT RESULTS IS NOT POSSIBLE WITH AVAILABLE METHODS AND THE CURRENT STATE OF THE ART. PRODUCT LABELING STATES: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE REAGENT PERFORMS WITHIN SPECIFICATION. A GENERAL REAGENT ISSUE CAN BE EXCLUDED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S E601 MODULE SERIAL NUMBER WAS (B)(6). THE SERIAL NUMBER FOR THE E601 MODULE AT THE OTHER HOSPITAL WAS NOT PROVIDED. THE COMPETITOR METHOD WAS ABBOTT. SAMPLE MATERIAL FROM THE PATIENT WAS REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE PATIENT¿S CLINICAL PICTURE WHEN TESTED FOR ELECSYS HE4 (HE4) ON TWO COBAS E 601 MODULES. THE INITIAL RESULT FROM THE CUSTOMER'S E601 MODULE WAS 248 PMOL/L. THE PATIENT WAS TESTED FOR HE4 ON AN E601 MODULE AT A DIFFERENT HOSPITAL AND THE RESULT WAS 228.1 PMOL/L. THE PATIENT WAS TESTED BY A COMPETITOR METHOD AT A DIFFERENT HOSPITAL AND THE HE4 RESULT WAS 34.3 PMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118408 ELECSYS HE4 EPITHELIAL OVARIAN TUMOR ASSOCIATED ANTIGEN (HE4) TEST OIU ROCHE DIAGNOSTICS ASKU 04015630929641

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female