BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT REALTIME HIV-1 AMP REAGENT KIT

    MDR report key: 2708759 · Received February 9, 2012

    Report

    Report Number
    3005248192-2012-00010
    Event Type
    Malfunction
    Date Received
    February 9, 2012
    Date of Event
    January 12, 2012
    Report Date
    January 12, 2012
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP06000Q
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LETTER REGARDING OFF-LABEL USE OF THE REALTIME HIV-1 ASSAY WILL BE SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE ABBOTT REALTIME HIV-1 ASSAY IN AN IN VITRO REVERSE TRANSCRIPTION-POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR THE QUANTITATION OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) IN HUMAN PLASMA FROM HIV-1 INFECTED INDIVIDUALS. THE ABBOTT REALTIME HIV-1 ASSAY IS INTENDED FOR USE IN CONJUNCTION WITH CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS AS AN INDICATOR OF DISEASE PROGNOSIS AND FOR USE AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIRETROVIRAL TREATMENT AS MEASURED BY CHANGES IN PLASMA HIV-1 RNA LEVELS. THIS ASSAY IN IS NOT INTENDED TO BE USED AS A SCREENING TEST FOR HIV-1 OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HIV-1 INFECTION. A CUSTOMER AT (B)(6) REPORTED THAT ERROR CODE 4454 WAS GENERATED FOR PT SAMPLES WHEN RUNNING THE REALTIME HIV-1 ASSAY, AND THIS CAUSED ADVERSE IMPACT TO PT MANAGEMENT. THE CUSTOMER INDICATED THAT THE PT SAMPLES WERE FROM RECENTLY DECEASED ORGAN DONORS. THE CUSTOMER STATED THAT WHEN A RESULT IS NOT GENERATED, THE TRANSPLANT IS ON HOLD AND THE TRANSPLANT RECIPIENT IS AFFECTED. CLARIFICATION WAS RECEIVED FROM THE CUSTOMER THAT NO TRANSPLANT RECIPIENTS WERE ACTUALLY ADVERSELY AFFECTED DUE TO THE ERROR CODES THAT WERE GENERATED. THE CUSTOMER WAS INSTRUCTED THAT THE REALTIME HIV-1 ASSAY IS NOT INTENDED TO BE USED AS A SCREENING TEST FOR HIV-1 OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HIV-1 INFECTION AS STATED IN THE ASSAY PACKAGE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT REALTIME HIV-1 AMP REAGENT KIT NONE MZF ABBOTT MOLECULAR, INC. 434358

    Patients

    Seq Age Sex Outcome Treatment
    1