BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    MDR report key: 8392127 · Received March 5, 2019

    Report

    Report Number
    1221359-2019-00014
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    October 6, 2016
    Report Date
    March 5, 2019
    Manufacturer
    ALERE SCARBOROUGH INC.
    Product Code
    MZF
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REQUIRED INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER AND MEDICAL HISTORY, WAS NOT AVAILABLE AND THEREFORE A ROOT CAUSE INVESTIGATION WAS NOT PERFORMED. NOTWITHSTANDING THE ABOVE, 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. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Description of Event or Problem · 1

    (B)(6) RESULTS WERE REPORTED WITH THE ALERE DETERMINE HIV 1/2 AG/AB COMBO. THE (B)(6) RESULTS WERE NOT CONFIRMED BY A REFERENCE LAB (TEST METHOD UNKNOWN). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. THE PATIENT'S GENDER, PREGNANCY STATUS, TREATMENT AND PATIENT OUTCOME WERE UNKNOWN. NO DEVICE LOT NUMBER WAS PROVIDED. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185002 ALERE DETERMINE HIV 1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ALERE SCARBOROUGH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1