BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HIV AG/AB COMBO REAGENT KIT

    MDR report key: 22792045 · Received August 13, 2025

    Report

    Report Number
    3002809144-2025-00262
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 18, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZF
    UDI-DI
    00380740121785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT A NEW SAMPLE FROM THE PATIENT WAS RECEIVED, AND THE HIV WESTERN BLOT TEST SHOWED A RESULT OF ¿NO BANDS". THEREFORE, THE CUSTOMER BELIEVES THE FINAL RESULT OF THE SAMPLE GENERATED ON (B)(6) 2025 WITH A RESULT OF 0.09 S/CO NON-REACTIVE IS CORRECT AND IS NO LONGER QUESTIONING THE NON-REACTIVE ALINITY I HIV AG/AB COMBO RESULT AS INCORRECT. BASED UPON THIS NEW INFORMATION PROVIDED, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT AND NO ADDITIONAL INFORMATION WILL BE SUBMITTED.

    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: 8P07-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 8P07-21 / 31 WITH 510K/PMA/BLA NUMBER: P090080 ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NON-REACTIVE ALINITY I HIV AG/AB COMBO RESULT FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 INITIAL RESULT (B)(6) 13.67 S/CO, SECOND RESULT (B)(6) = 33.55 S/CO, (B)(6) 2025 THIRD RESULT (B)(6) = 0.09 S/CO. HIV ROCHE COBAS RESULT = 24.40 COI (REACTIVE). HIV WESTERN BLOT: NO BANDS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON 13AUG2025. THE CUSTOMER REPORTED THAT A NEW SAMPLE FROM THE PATIENT WAS RECEIVED, AND THE HIV WESTERN BLOT TEST SHOWED A RESULT OF ¿NO BANDS". THEREFORE, THE CUSTOMER BELIEVES THE FINAL RESULT OF THE SAMPLE GENERATED ON (B)(6) 2025 WITH A RESULT OF 0.09 S/CO NON-REACTIVE IS CORRECT AND IS NO LONGER QUESTIONING THE NON-REACTIVE ALINITY I HIV AG/AB COMBO RESULT AS INCORRECT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NON-REACTIVE ALINITY I HIV AG/AB COMBO RESULT FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025 INITIAL RESULT (B)(6) 13.67 S/CO, SECOND RESULT (B)(6) = 33.55 S/CO, ON (B)(6) 2025 THIRD RESULT (B)(6) = 0.09 S/CO. HIV ROCHE COBAS RESULT = 24.40 COI (REACTIVE). HIV WESTERN BLOT: NO BANDS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66052 ALINITY I HIV AG/AB COMBO REAGENT KIT TEST, HIV DETECTION MZF ABBOTT GMBH 72378BE00 00380740121785

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).