BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7554605 · Received May 30, 2018

    Report

    Report Number
    1221359-2018-00135
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    November 14, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED ON RETAINED KIT LOT 160406 WITH THE FOLLOWING INTERNAL WHOLE BLOOD CONTROL SAMPLES: (B)(6). THE KIT PERFORMED AS EXPECTED. ADDITIONALLY, QC DATA AND BATCH RECORDS FOR LOT 160406 WERE REVIEWED. RELEASE TESTING WAS VALID AND THE LOT WAS FOUND TO BE PERFORMING AS EXPECTED. A REVIEW OF THE COMPLAINTS REPORTED FALSE POSITIVE OR UNCONFIRMED FALSE POSITIVE RELATED TO LOT NUMBER 160406 SHOWED THAT THE COMPLAINT RATE IS 0.052%. 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. 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 LABELED CLAIMS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A (B)(6) RESULT ON A BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE (B)(6). UNIGOLD AND EIA 4TH GENERATION TESTS WERE (B)(6), RNA LESS THAN 20 COPIES/ML. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. PATIENT GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOMES 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 SCARBOROUGH, INC., HOWEVER THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED (B)(6) TO (B)(6) 2018 AT ALERE SCARBOROUGH, INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397019 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 160406 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1