BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB-IGG

    MDR report key: 24775524 · Received April 3, 2026

    Report

    Report Number
    3002809144-2026-00082
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 1, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOL
    UDI-DI
    00380740115319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. SECTION E1 PHONE NUMBER CHARACTER LIMIT EXCEEDED. THE FULL CHARACTER PHONE NUMBER IS (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C29 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6L27, AND 510K/PMA/BLA OF K113704. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT HAVAB-IGG FOR TWO PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE > 1.00 S/CO): (B)(6) 2026, SID (B)(6), 35-YEAR-OLD FEMALE, INITIAL HAVAB-IGG RESULT= 1.37 S/CO; REPEAT RESULT= 0.22 S/CO. (B)(6) 2026, SID (B)(6), 38-YEAR-OLD FEMALE, INITIAL HAVAB-IGG RESULT= 1.30 S/CO; REPEAT RESULT= 0.54 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835409 ARCHITECT HAVAB-IGG HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) LOL ABBOTT GMBH 79089BE00 00380740115319

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6)