BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HIV AG/AB COMBO REAGENT KIT

    MDR report key: 16003506 · Received December 19, 2022

    Report

    Report Number
    3002809144-2022-00445
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    November 25, 2022
    Report Date
    January 23, 2023
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDRESS 1: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P07-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P07-21/ -31. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE NONREACTIVE ALINITY I HIV AG/AB COMBO RESULT INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW. IN-HOUSE TESTING OF RETAINED REAGENT KIT WAS ALSO COMPLETED. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. HOWEVER, DATA WERE INCONCLUSIVE AS REACTIVE AND NON-REACTIVE RESULTS WERE OBTAINED WITH DIFFERENT METHODS, BUT NO RNA RESULTS WERE PROVIDED TO DETERMINE IF THE BABY IS REALLY HIV INFECTED OR IF POTENTIALLY HIV ANTIBODIES FROM THE BABY DERIVE FROM MATERNAL-INFANT TRANSMISSION. TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 42104BE01 AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED, AND SPECIFICATIONS WERE MET WHICH INDICATES THE PRODUCT IS PERFORMING AS EXPECTED. IN ADDITION, THE CLINICAL SENSITIVITY WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (ZEPTOMETRIX HIV 9013 AND HIV 9016). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO HIV TEST RESULTS PROVIDED BY ZEPTOMETRIX AND THE REAGENT LOT DETECTED THE SAME BLEEDS AS REACTIVE FOR THE SEROCONVERSION PANELS. BASED ON THESE DATA, IT SHOWED THAT THE SENSITIVITY PERFORMANCE OF THE LOT IS NOT ADVERSELY AFFECTED. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I HIV AG/AB COMBO REAGENT FOR LOT 42104BE01 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NONREACTIVE ALINITY I HIV AG/AB COMBO RESULTS ON AN 18-MONTH-OLD INFANT WHOSE MOTHER HAD A CONFIRMED DIAGNOSIS OF HIV. AFTER COMPLETING THE PROPHYLACTIC THERAPY, THE INFANT WAS GETTING BREAST MILK FROM THE MOTHER. THE INFANT¿S HIV RESULTS FROM OTHER METHODS WERE POSITIVE. THE FOLLOWING DATA WAS PROVIDED: ALINITY RESULT = 0.42 S/CO (NONREACTIVE). ALINITY RESULT WITH HBT (HETEROPHILIC BLOCKING TUBING) = 0.45 S/CO (NONREACTIVE). ALINITY RESULT POST HIGH-SPEED CENTRIFUGATION = NONREACTIVE. MINDRAY RESULT =1.23 (POSITIVE). MINDRAY RESULT WITH HBT (HETEROPHILIC BLOCKING TUBE) = 1.23 (POSITIVE). MINDRAY RESULT AFTER HIGH-SPEED CENTRIFUGATION = POSITIVE. ELISA RESULT = POSITIVE. COLLOIDAL GOLD RESULT = NEGATIVE. COLLOIDAL SELENIUM RESULT = NEGATIVE. WESTERN BLOT RESULT = NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747948 ALINITY I HIV AG/AB COMBO REAGENT KIT TEST, HIV DETECTION MZF ABBOTT GMBH 42104BE01

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).