BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7440497 · Received April 18, 2018

    Report

    Report Number
    1221359-2018-00015
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    March 20, 2018
    Report Date
    April 18, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE (B)(4) ON RETAINED KIT LOT S 095651 AND 091493 WITH THE FOLLOWING INTERNAL WHOLE BLOOD CONTROL SAMPLES: (B)(6). ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOTS 095651 AND 091493 WERE REVIEWED. BOTH OF THESE LOTS MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED (B)(6) RELATED TO LOT NUMBER 095651 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED (B)(6) RELATED TO LOT NUMBER 091493 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. AS DESCRIBED IN THE PACKAGE INSERT UNDER THE SECTION LIMITATIONS OF THE TEST: "SPECIMENS FROM INDIVIDUALS INFECTED WITH HIV-1 AND/OR HIV-2 WHO ARE RECEIVING ANTIRETROVIRAL (ART) THERAPY MAY PRODUCE FALSE NEGATIVE TEST RESULTS." "A NONREACTIVE RESULT DOES NOT PRECLUDE THE POSSIBILITY OF EXPOSURE TO HIV OR INFECTION WITH HIV." 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 LABELED CLAIMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A (B)(6) RESULT WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO ON A WHOLE BLOOD SAMPLE FROM A (B)(6) MALE, KNOWN (B)(6) FOR (B)(6). TWO TESTS WERE COMPLETED FROM TWO DIFFERENT LOT NUMBERS (091493 AND 095651). BOTH TESTS HAD VALID CONTROL LINES PRESENT AND WERE (B)(6) FOR BOTH (B)(6). CONFIRMATORY TESTING WAS REPORTED AS "(B)(6)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284031 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 091493 10811877010293

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR