BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 5499875 · Received March 15, 2016

    Report

    Report Number
    3008754095-2016-00008
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    February 8, 2016
    Report Date
    February 8, 2016
    Manufacturer
    ORGENICS LTD
    Product Code
    MZF
    PMA / PMN Number
    120037/0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT INVOLVED A REPORTED POTENTIAL (B)(6) RESULT. THE CONFIRMATORY TESTS WERE PERFORMED AND THE RESULT WAS (B)(6). THE LOT NUMBER WAS NOT PROVIDED, THE SAMPLE WAS NOT RETURNED FOR FURTHER TESTING AND THEREFORE ORGENICS WAS UNABLE TO PERFORM SPECIFIC INVESTIGATION. AN ATTEMPT TO GATHER ADDITIONAL INFORMATION WAS MADE, HOWEVER, PATIENT DETAILS WERE NOT AVAILABLE. BASED ON THE DETAILS PROVIDED BY THE CUSTOMER THE CAUSE OF (B)(6) MAY BE DUE TO INCORRECT INTERPRETATION OF RESULTS BY THE USER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL (B)(6) RESULT. THE PATIENT TESTED (B)(6) WITH (B)(6) CASCADE TEST AND WITH RNA QUANTITATIVE PCR. THE TEST WAS THEN REPEATED ON THE ALERE DETERMINE COMBO STRIPS WITH THE SAME SAMPLE AND THE RESULT WAS (B)(6). THERE WERE NO ADVERSE PATIENT OUTCOMES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156989 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ORGENICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1