BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB-IGG

    MDR report key: 24260074 · Received February 4, 2026

    Report

    Report Number
    3002809144-2026-00022
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 27, 2026
    Report Date
    April 20, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOL
    UDI-DI
    00380740115319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C29 (HAVAB-IGG) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6L27 (HAVAB-G) WITH 510K/PMA/BLA NUMBER K113704. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE ARCHITECT HAVAB IGG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT HAVAB IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 79089BE00. THE DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES FOR THE LOT NUMBER. THE OVERALL PERFORMANCE OF ARCHITECT HAVAB IGG WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE NUMBER OF STANDARD DEVIATIONS TO CUTOFF AND PATIENT MEDIAN VALUES OF THE NEGATIVE POPULATION FOR THE COMPLAINT LOT(S) ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY IN THE FIELD. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HAVAB IGG REAGENT LOT 79089BE00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT HAVAB-IGG RESULTS GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR A 45-YEAR-OLD MALE PATIENT. THE CUSTOMER BELIEVES THE NEGATIVE RESULTS ARE CORRECT. ON (B)(6) 2026 SID (B)(6) NEGATIVE FOR HAVAB-IGG (NO SPECIFIC RESULT PROVIDED) ON (B)(6) 2026 NEW SAMPLE = 1.29 S/C0, REPEAT RESULT = 0.61 S/CO PATIENT HAD TWO NEW SAMPLES WITH SID (B)(6) WITH RESULT = 2.02 S/CO AND SID (B)(6) WITH 0.79 S/CO NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ARCHITECT HAVAB-IGG RESULTS GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR A 45-YEAR-OLD MALE PATIENT. THE CUSTOMER BELIEVES THE NEGATIVE RESULTS ARE CORRECT. (B)(6) 2026 SID (B)(6) NEGATIVE FOR HAVAB-IGG (NO SPECIFIC RESULT PROVIDED) (B)(6) 2026 NEW SAMPLE = 1.29 S/C0, REPEAT RESULT = 0.61 S/CO PATIENT HAD TWO NEW SAMPLES WITH SID (B)(6) WITH RESULT = 2.02 S/CO AND SID (B)(6) WITH 0.79 S/CO NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544759 ARCHITECT HAVAB-IGG HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) LOL ABBOTT GMBH 79089BE00 00380740115319

    Patients

    Seq Age Sex Outcome Treatment
    1