BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 9593087 · Received January 15, 2020

    Report

    Report Number
    1221359-2020-00002
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 20, 2019
    Report Date
    January 15, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP120037-0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 PATIENT'S MEDICAL HISTORY, 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. ABBOTT DIAGNOSTICS (B)(4). WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A (B)(6) (AG/AB NOT SPECIFIED) RESULT WITH THE ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST. CONFIRMATION TESTING WAS NOT REPORTED. THE PATIENT GENDER, SAMPLE TYPE, PREGNANCY STATUS, TREATMENT AND OUTCOME ARE UNKNOWN. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF A MALFUNCTION OCCURRED. MULTIPLE ATTEMPTS TO GAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56769 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV 1/2 AG/AB MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1