BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7589391 · Received June 11, 2018

    Report

    Report Number
    1221359-2018-00216
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Report Date
    June 11, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN-HOUSE TESTING WAS PERFORMED ON RETAINED KIT LOT 160705 WITH THE FOLLOWING INTERNAL WHOLE BLOOD 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 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. 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 RESULTS OBTAINED MAY POSSIBLY BE RELATED TO THE PATIENT SAMPLE. THE SAMPLE MAY HAVE CONTAINED SPECIFIC SUBSTANCES WHICH MAY HAVE AFFECTED THE RESULTS. THE AVAILABLE EVIDENCE SUGGESTS THAT THE DEVICE IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    A (B)(6) RESULT WAS REPORTED ON A SAMPLE (UNKNOWN TYPE) TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. DATE OF EVENT WAS NOT PROVIDED. THE PATIENT WAS CONFIRMED (B)(6) BY AN UNKNOWN METHOD. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY ALERE (B)(4) HOWEVER, 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
    430893 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