BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 7589358 · Received June 11, 2018

    Report

    Report Number
    1221359-2018-00203
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    May 22, 2017
    Report Date
    June 11, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED ON RETAINED KIT LOTS 161218 AND 170223 WITH THE FOLLOWING INTERNAL WHOLE BLOOD CONTROL SAMPLES: (B)(6). THE KITS PERFORMED AS EXPECTED. ADDITIONALLY, QC DATA AND BATCH RECORDS FOR LOT 161218 AND 170223 WERE REVIEWED. RELEASE TESTING WAS VALID AND THE LOTS WERE FOUND TO BE PERFORMING AS EXPECTED. A REVIEW OF THE COMPLAINTS REPORTED (B)(6) OR UNCONFIRMED (B)(6) RELATED TO LOT NUMBER 161218 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED (B)(6) OR UNCONFIRMED (B)(6) RELATED TO LOT NUMBER 170223 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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 THESE DEVICE LOTS ARE PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A (B)(6) AB RESULT ON A CAPILLARY WHOLE BLOOD SAMPLE TESTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. CUSTOMER REPEATED THE PATIENT'S TEST WITH A SECOND LOT WHICH ALSO GAVE A (B)(6) AB RESULT. QUEST (B)(6) AG AND ABS 4TH GENERATION TEST, WITH REFLEXES, WAS (B)(6). 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 (B)(4), INC.; HOWEVER, THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED FEBRUARY 26TH TO MARCH 2ND, 2018 AT ALERE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430502 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC. 161218 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1