BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HE4 REAGENT KIT

    MDR report key: 24280032 · Received February 6, 2026

    Report

    Report Number
    3002809144-2026-00026
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 19, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    OIU
    UDI-DI
    00380740166090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02P54-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2P54-27, WITH 510K NUMBER K093957. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT HE4 REAGENT LOT 73537FP01 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSELY DEPRESSED RESULTS. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT 73537FP01 AND THE COMPLAINT ISSUE. THE CUSTOMER USED LOT 73537FP01 (EXPIRATION DATE; 01/21/2026) ON (B)(6) 2026 WHICH IS PAST THE EXPIRATION DATE OF THE PRODUCT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HE4 REAGENT LOT 73537FP01 WAS IDENTIFIED. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT HE4 RESULTS FOR A 54-YEAR-OLD FEMALE WITH OVARIAN CANCER. THE FOLLOWING DATA WAS PROVIDED: HE4 INITIAL RESULT WAS 69.1 PMOL/L, RETEST RESULT 68.8 PMOL/L (NORMAL REFERENCE RANGE 0-70 PMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT HE4 RESULTS FOR A 54-YEAR-OLD FEMALE WITH OVARIAN CANCER. THE FOLLOWING DATA WAS PROVIDED: HE4 INITIAL RESULT WAS 69.1 PMOL/L, RETEST RESULT 68.8 PMOL/L (NORMAL REFERENCE RANGE 0-70 PMOL/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164868 ARCHITECT HE4 REAGENT KIT TEST, EPITHELIAL OVARIAN TUMOR ASSOCIATED ANTIGEN (HE4) OIU ABBOTT GMBH 73537FP01 00380740166090

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female ARC I2K PROC MOD, 03M74-01, (B)(6),| ARC I2K PROC MOD, 03M74-01, (B)(6).