BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7554548 · Received May 30, 2018

    Report

    Report Number
    1221359-2018-00062
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    November 7, 2016
    Report Date
    May 30, 2018
    Manufacturer
    ALERE SCARBOROUGH INC.
    Product Code
    MZF
    UDI-DI
    07290015003735
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN-HOUSE TESTING WAS PERFORMED ON RETAINED KIT LOT 160705 WITH THE FOLLOWING INTERNAL SERUM/PLASMA CONTROL SAMPLES: HIV-1 POSITIVE, HIV-2 POSITIVE, P24 POSITIVE, AND HIV NEGATIVE. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 160705 WAS REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CUSTOMER RETURNED THE PATIENT SAMPLE AND IT WAS TESTED WITH RETAIN DEVICES OF THE SAME KIT LOT. THE TEST WAS VALID WITH (B)(6) RESULTS. THE (B)(6) RESULT WAS NOT REPLICATED. THE SAMPLE WAS TESTED 3 WEEKS AFTER THE INITIAL CUSTOMER EVENT. THE STORAGE AND HANDLING OF THIS SAMPLE BY THE CUSTOMER IS UNKNOWN. BASED ON THE INFORMATION AVAILABLE, IT APPEARS A MALFUNCTION MAY HAVE OCCURRED WITH THE TEST PERFORMED AT THE CUSTOMER SITE AS THE TEST PERFORMED WITH THE RETURNED PATIENT SAMPLE ALIGNED WITH THE CONFIRMATORY RESULTS. HOWEVER THE SAMPLE WAS TESTED 3 WEEKS AFTER THE INITIAL CUSTOMER EVENT. THE STORAGE AND HANDLING OF THIS SAMPLE BY THE CUSTOMER IS UNKNOWN. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE OR UNCONFIRMED FALSE POSITIVE RELATED TO LOT NUMBER 160705 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. THE EXACT ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    A FALSE POSITIVE AB RESULT WAS REPORTED ON A SERUM SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE PATIENT WAS COMFIRMED (B)(6) BY A 4TH GENERATION TEST, BIORAD GS HIV AG/AB EIA. IT APPEARS A MALFUNCTION MAY HAVE OCCURRED BECAUSE THE RETURNED SAMPLE TESTED THREE WEEKS LATER WAS NEGATIVE. THE PATIENT TREATMENT AND OUTCOME WERE UNKNOWN. THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396030 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 160705 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR