BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HIV AG/AB COMBO REAGENT KIT

    MDR report key: 21657996 · Received March 20, 2025

    Report

    Report Number
    3002809144-2025-00106
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    February 7, 2025
    Report Date
    May 13, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZF
    UDI-DI
    00380740121785
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. SECTION A1: PATIENT IDENTIFIER COMPLETE ENTRY: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 08P07-32, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 08P07-31, AND A PMA NUMBER OF P090080.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE NONREACTIVE ALINITY I HIV AG/AB COMBO 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 TESTING OF RETAINED REAGENT KITS OF THE COMPLAINT LOT NUMBER. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCT AND THE LIKELY CAUSE LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. RETURN TESTING WAS NOT COMPLETED, AS RETURNS WERE NOT AVAILABLE. SENSITIVITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 70212BE00, STORED AT THE RECOMMENDED STORAGE CONDITION. THE CLINICAL SENSITIVITY OF THE LOT WAS EVALUATED BY TESTING A COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (ZEPTOMETRIX HIV 9016). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT HIV TEST RESULTS PROVIDED BY ZEPTOMETRIX. THE LOT DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANELS. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE LOT IS NOT ADVERSELY AFFECTED. ALINITY I HIV AG/AB COMBO IS EQUIVALENT TO ARCHITECT HIV AG/AB COMBO AS THEY SHARE THE SAME BULK REAGENTS. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ALINITY I HIV AG/AB COMBO, LOT NUMBER 70212BE00, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I HIV AG/AB COMBO RESULTS FOR A PATIENT DIAGNOSED WITH HIV. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): SAMPLE ID: (B)(6) RESULT, ON (B)(6) 2025, WAS 0.62 S/CO, WHEN TESTED WITH A BIOMÉRIEUX DUO ASSAY, THE RESULT WAS 4.18 INDEX, WHICH IS POSITIVE. THE PATIENT WAS RETESTED ON (B)(6) 2025, AND THE RESULT WAS 0.41 S/CO. THE PATIENT¿S PREVIOUS RESULTS WERE PROVIDED: ON (B)(6) 2025 ALINITY RESULT WAS 8.25 S/CO, BIOMÉRIEUX DUO RESULT WAS 6.97 INDEX. ON (B)(6) 2025 ALINITY RESULT WAS 18.17 S/CO, BIOMÉRIEUX DUO RESULT WAS 7.40 INDEX. ON (B)(6) 2025 ALINITY RESULT WAS 1.43 S/CO, BIOMÉRIEUX DUO RESULT WAS 5.46 INDEX. ON (B)(6) 2025 ALINITY RESULT WAS 0.75 S/CO, BIOMÉRIEUX DUO RESULT WAS 3.66 INDEX. ALL WESTERN BLOT TESTING RESULTS WERE INDETERMINATE FOR THIS PATIENT. IT WAS NOTED THAT THE PATIENT STARTED ANTI-RETROVIRAL TREATMENT ON (B)(6) 2025. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I HIV AG/AB COMBO RESULTS FOR A PATIENT DIAGNOSED WITH HIV. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): SAMPLE ID (B)(6), RESULT, ON (B)(6) 2025, WAS 0.62 S/CO, WHEN TESTED WITH A BIOMÉRIEUX DUO ASSAY, THE RESULT WAS 4.18 INDEX, WHICH IS POSITIVE. THE PATIENT WAS RETESTED ON (B)(6) 2025, AND THE RESULT WAS 0.41 S/CO. THE PATIENT¿S PREVIOUS RESULTS WERE PROVIDED: ON (B)(6)2025, ALINITY RESULT WAS 8.25 S/CO, BIOMÉRIEUX DUO RESULT WAS 6.97 INDEX, ON (B)(6) 2025, ALINITY RESULT WAS 18.17 S/CO, BIOMÉRIEUX DUO RESULT WAS 7.40 INDEX, ON (B)(6) 2025, ALINITY RESULT WAS 1.43 S/CO, BIOMÉRIEUX DUO RESULT WAS 5.46 INDEX, ON (B)(6) 2025, ALINITY RESULT WAS 0.75 S/CO, BIOMÉRIEUX DUO RESULT WAS 3.66 INDEX. ALL WESTERN BLOT TESTING RESULTS WERE INDETERMINATE FOR THIS PATIENT. IT WAS NOTED THAT THE PATIENT STARTED ANTI-RETROVIRAL TREATMENT ON (B)(6) 2025. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334484 ALINITY I HIV AG/AB COMBO REAGENT KIT TEST, HIV DETECTION MZF ABBOTT GMBH 70212BE00 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)