BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 8199167 · Received December 27, 2018

    Report

    Report Number
    1221359-2018-00561
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Report Date
    December 27, 2018
    Manufacturer
    ALERE SCARBOROUGH INC.
    Product Code
    MZF
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO KIT LOT NUMBER WAS PROVIDED FOR A SPECIFIC INVESTIGATION. NO SAMPLE WAS RETURNED FOR FURTHER TESTING, AND NO ADDITIONAL INFORMATION WAS PROVIDED. A REVIEW OF COMPLAINT TRENDS REVEALED THAT ALL OF THE ALERE DETERMINE HIV ½ AG/AB COMBO LOTS ARE PERFORMING ACCORDING TO LABEL CLAIMS. THE EXACT ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE AVAILABLE EVIDENCE SUGGESTS THAT THE DEVICE IS PERFORMING WITHIN LABELED CLAIMS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED (B)(6) RESULTS WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT(S) GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. THE EXACT NUMBER OF PATIENTS AND THE DATE OF OCCURRENCE(S) ARE UNKNOWN. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039250 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1