BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 25164243 · Received May 13, 2026

    Report

    Report Number
    1417592-2026-01192
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 13, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    NFT
    UDI-DI
    10193489017540
    PMA / PMN Number
    K182701
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT FALSE NEGATIVES ARE BEING PROVIDED WHILE USING THE DRUG SPECIMEN CUPS. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FALSE NEGATIVES ARE BEING PROVIDED WHILE USING THE DRUG SPECIMEN CUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258728 MEDLINE TEST, DRUG, 12 PANEL, A.D NFT MEDLINE INDUSTRIES, LP W512507024 10193489017540

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown