BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 8349653 · Received February 19, 2019

    Report

    Report Number
    1221359-2019-00009
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    January 31, 2019
    Report Date
    February 19, 2019
    Manufacturer
    ALERE SCARBOROUGH INC.
    Product Code
    MZF
    UDI-DI
    10811877010293
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE SCARBOROUGH ON RETAINED KIT LOT 101439 WITH THE FOLLOWING INTERNAL WHOLE BLOOD AND SERUM PLASMA CONTROL SAMPLES: (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 101439 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS AND THERE WERE NO NOTES INDICATING CONFLICTING RESULTS WITHIN THE 20-30 MINUTES READING TIMEFRAME. A PHOTOGRAPH OF THE TEST DEVICE WHICH WAS PROVIDED BY THE CUSTOMER WAS REVIEWED. A SINGLE ALERE DETERMINE HIV 1/2 AG/AB COMBO TEST DEVICE WAS OBSERVED WITH A VALID CONTROL LINE, AND A VISIBLE AG LINE. NO AB LINE WAS VISIBLE. THE SAMPLE PAD WAS OBSERVED TO BE SATURATED, AND THE SAMPLE APPEARED TO MIGRATE COMPLETELY UP THE TEST STRIP. A REVIEW OF THE COMPLAINTS REPORTED CONFLICTING RESULTS RELATED TO LOT NUMBER 101439 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 AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN ALERE DETERMINE HIV 1/2 AG/AB COMBO TEST RESULT WAS INITIALLY READ AS (B)(6) AT 20 MINUTES AND THEN APPEARED (B)(6) FOR AG (FAINT LINE) AT OR BEFORE 30 MINUTES. THE PATIENT WAS RETESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO ON A DIFFERENT DAY, AND THE RESULTS WERE (B)(6) AT 30 MINUTES. THE CONFLICTING RESULTS ORIGINALLY OBSERVED ON THE FIRST TEST WITHIN THE READING TIME-FRAME OF 20-30 MINUTES, SUGGEST A MALFUNCTION MAY HAVE OCCURRED AS THE RESULTS WOULD BE EXPECTED TO BE THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144249 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 101439 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1