BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 7382276 · Received March 29, 2018

    Report

    Report Number
    1221359-2018-00012
    Event Type
    Malfunction
    Date Received
    March 29, 2018
    Date of Event
    November 12, 2017
    Report Date
    March 29, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ALERE SCARBOROUGH ON RETAINED KIT LOT 170406 WITH THE FOLLOWING INTERNAL WHOLE BLOOD CONTROL SAMPLES: (B)(6) AND HIV NEGATIVE. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 170406 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 170406 SHOWED THAT THE COMPLAINT RATE IS 0.014%. THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ALERE SCARBOROUGH 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 FALSE POSITIVE (VENOUS WHOLE BLOOD) AB RESULT USING THE ALERE DETERMINE (B)(6) 1/2 AG/AB COMBO. SUBSEQUENT CONFIRMATORY TESTING DEMONSTRATED NEGATIVE RESULTS. TEST RESULTS WERE OBTAINED FROM A PATIENT IN ACTIVE LABOR, WEEK 39. THERE WERE NO ADVERSE PATIENT OUTCOMES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223423 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH, INC. 170406 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1