BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HE4

    MDR report key: 19730333 · Received July 12, 2024

    Report

    Report Number
    1823260-2024-02005
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    May 21, 2024
    Report Date
    August 9, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    OIU
    UDI-DI
    04015630939664
    PMA / PMN Number
    K980887
    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 CEA REAGENT LOT NUMBER WAS 749425 WITH AN EXPIRATION DATE OF 31-JAN-2025. THE CYFRA 21-1 REAGENT LOT NUMBER WAS 711310 WITH AN EXPIRATION DATE OF 30-NOV-2024. THE COBAS 8000 CORE UNIT SERIAL NUMBER WAS (B)(6). THE ALARM TRACE SHOWED MULTIPLE ABNORMAL SAMPLE ASPIRATION ALARMS AND ABNORMAL SAMPLE PROBE MOVEMENT ALARMS ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, THE HE4 RESULT WAS 98.37 PMOL/L AFTER A MANUAL DILUTION OF 1:20 USING DILUENT UNIVERSAL. THE CUSTOMER USED AN INCORRECT DILUTION SOLUTION FOR THE HE4 ASSAY. THE CUSTOMER WAS ADVISED TO USE DILUENT MULTIASSAY AS THE PRODUCT LABELING STATES: "SAMPLES WITH HE4 CONCENTRATIONS ABOVE THE MEASURING RANGE CAN BE DILUTED WITH DILUENT MULTIASSAY." ON (B)(6) 2024 THE SAMPLE WAS REQUESTED BUT IT WAS NOT AVAILABLE FOR INVESTIGATION. CALIBRATION AND QC DATA WERE REQUESTED BUT WERE NOT PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CEA, CYFRA 21-1, AND HE4 REAGENTS PERFORM WITHIN THE SPECIFIED RANGES. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS NOT MATCHING THE PATIENT'S CLINICAL PICTURE FOR 1 PATIENT SERUM SAMPLE TESTED WITH ELECSYS CEA ASSAY, ELECSYS CYFRA 21-1 ASSAY, AND ELECSYS HE4 ASSAY ON A COBAS 8000 COBAS E602 MODULE WHEN COMPARED TO A NON-ROCHE ANALYZER. THIS MEDWATCH WILL APPLY TO THE HE4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CEA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CYFRA 21-1 ASSAY. THE SAMPLE WAS INITIALLY TESTED ON THE E602 ANALYZER AND REPEATED ON A NON-ROCHE ANALYZER ON (B)(6) 2024. TWO TEST RESULTS WERE CONSISTENT. CEA: INITIAL RESULT: 13.62 NG/ML. REPEAT RESULT: 13.37 NG/ML. CYFRA 21-1: INITIAL RESULT: 54.37 NG/ML. REPEAT RESULT: 55.767 NG/ML. HE4: INITIAL RESULT: 1500 PMOL/L (ACCOMPANIED BY A DATA FLAG). RESULT AFTER DILUTION: 1967.4 PMOL/L. REPEAT RESULT: 1500 PMOL/L (ACCOMPANIED BY A DATA FLAG). RESULT AFTER DILUTION: 4151.754 PMOL/L. THE ABOVE PATIENT TEST RESULTS WERE CONSIDERED HIGHER THAN THE NORMAL REFERENCE RANGE. THE CUSTOMER SUSPECTED AN INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232803 ELECSYS HE4 EPITHELIAL OVARIAN TUMOR ASSOCIATED ANTIGEN (HE4) TEST OIU ROCHE DIAGNOSTICS 738510 04015630939664

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown