BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT IVANCOMYCIN

    MDR report key: 25228936 · Received May 20, 2026

    Report

    Report Number
    3002809144-2026-00131
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 20, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LEH
    UDI-DI
    00380740155964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). 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 1P30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1P30-24 / 28, WITH 510K/PMA/BLA NUMBER K123947. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DECREASED ARCHITECT IVANCOMYCIN RESULT GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR AN 85-YEAR-OLD FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2026, SID (B)(6), 10.3 UG/ML, REPEAT RESULT = 23.8 UG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228794 ARCHITECT IVANCOMYCIN RADIOIMMUNOASSAY, VANCOMYCIN LEH ABBOTT GMBH 00725D000 00380740155964

    Patients

    Seq Age Sex Outcome Treatment
    1