BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7571524 · Received June 5, 2018

    Report

    Report Number
    1221359-2018-00331
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    January 19, 2018
    Report Date
    June 5, 2018
    Manufacturer
    ALERE SCARBOROUGH INC.
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE (B)(4) ON RETAINED KIT LOT 091045 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 091045 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 091045 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ALERE (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. 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 THIS DEVICE LOT IS PERFORMING WITHIN LABLED CLAIMS.

    Description of Event or Problem · 1

    A (B)(6) RESULT WAS REPORTED ON A FINGERSTICK WHOLE BLOOD SAMPLE FROM A PREGNANT FEMALE PATIENT TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE BIORAD ANTIGEN/ANTIBODY EIA COMBO ASSAY WAS USED TO CONFIRM THE PATIENT AS (B)(6). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. IT WAS UNKNOWN IF ART WAS ADMINISTERED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414147 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 091045 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1