BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7566046 · Received June 4, 2018

    Report

    Report Number
    1221359-2018-00316
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    September 28, 2016
    Report Date
    May 30, 2018
    Manufacturer
    ALERE SCARBOROUGH INC.
    Product Code
    MZF
    UDI-DI
    07290015003742
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED ON RETAINED KIT LOT 160515 WITH THE FOLLOWING INTERNAL WHOLE BLOOD CONTROL SAMPLES: (B)(6). THE KIT PERFORMED AS EXPECTED. ADDITIONALLY, QC DATA AND BATCH RECORDS FOR LOT 160515 WERE REVIEWED. RELEASE TESTING WAS VALID AND THE LOT WAS FOUND TO BE PERFORMING AS EXPECTED. A REVIEW OF THE COMPLAINTS REPORTED (B)(6) OR UNCONFIRMED (B)(6) RELATED TO LOT NUMBER 160515 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. IN HOUSE TESTING WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CONFLICTING RESULTS ON A FINGERSTICK WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE (B)(6) AG/AB COMBO. THE SAME SAMPLE WAS USED TO PERFORM TWO TESTS. THE FIRST TEST RESULT WAS (B)(6) FOR AG/AB, AND THE SECOND TEST WAS (B)(6). IT IS UNKNOWN HOW MUCH TIME ELAPSED BETWEEN THE TWO TESTS, BUT IT IS POSSIBLE THEY OCCURRED ON THE SAME DAY. A 4TH GENERATION (B)(6) TEST WITH VENIPUNCTURE SAMPLE WAS (B)(6). BASED ON THE INFORMATION AVAILABLE IN THE CASE, IT APPEARS A MALFUNCTION MAY HAVE OCCURRED WITH ONE OF THE TWO CONFLICTING ALERE DETERMINE (B)(6) COMBO TESTS. PATIENT WAS MALE TRANSITIONING TO FEMALE TRANSGENDER INDIVIDUAL, WITH TREATMENT AND PATIENT OUTCOME UNKNOWN. THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN FDA OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408129 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 160515 07290015003742

    Patients

    Seq Age Sex Outcome Treatment
    1