BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 8734384 · Received June 26, 2019

    Report

    Report Number
    1221359-2019-00037
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    April 23, 2019
    Report Date
    July 11, 2019
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH INC.
    Product Code
    MZF
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ALERE SCARBOROUGH ON RETAINED KIT LOT 103698 WITH THE FOLLOWING INTERNAL WHOLE BLOOD CONTROL SAMPLES: HIV-1 POSITIVE, HIV-2 POSITIVE, P24 POSITIVE, AND HIV NEGATIVE. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS FOR LOT 103698 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE OR UNCONFIRMED FALSE POSITIVE RELATED TO LOT NUMBER 103698 SHOWED THAT THE COMPLAINT RATE IS 0.02%. 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 · 0

    BASED ON NEW INFORMATION RECEIVED FROM THE CUSTOMER, THIS REPORT REPRESENTS THE 1ST OF 3 FALSE POSITIVE PATIENT RESULTS WHICH OCCURRED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO ON BLOOD SAMPLES. A CONFIRMATORY TEST (NOT OTHERWISE SPECIFIED) WHICH WAS PERFORMED AT QUEST DIAGNOSTICS WAS NEGATIVE FOR HIV. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT WAS REPORTED AS FEMALE BUT PREGNANCY AND TREATMENT STATUS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE REQUIRED INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT AVAILABLE AND THEREFORE A ROOT CAUSE INVESTIGATION WAS NOT PERFORMED. A REVIEW OF COMPLAINTS' TREND REVEAL THAT ALL OF THE ALERE DETERMINE HIV 1/2 AG/AB COMBO BATCHES ARE PERFORMING ACCORDING TO LABEL CLAIMS. THE EXACT ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED (B)(6) RESULTS HAD OCCURRED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO SINCE (B)(6) 2019. NO DETAILS REGARDING CONFIRMATORY TESTING WAS PROVIDED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE EXACT NUMBER OF PATIENTS VERSES TEST RESULTS IS UNKNOWN. THE CUSTOMER STATED THAT ONE PATIENT MAY HAVE BEEN PREGNANT (BUT WAS UNSURE). NO OTHER PATIENT DETAILS SUCH AS TREATMENT OR PATIENT OUTCOMES WERE PROVIDED. NO EXACT DATES OF OCCURRENCES OR DEVICE LOT NUMBERS WERE PROVIDED. ATTEMPTS TO GAIN ADDITIONAL PATIENT INFORMATION WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528154 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ABBOTT DIAGNOSTICS SCARBOROUGH INC. 103698

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR