BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    124 OSOM COMBO HCG 25T KIT

    MDR report key: 3963675 · Received April 8, 2014

    Report

    Report Number
    2030538-2014-00001
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 5, 2014
    Report Date
    April 21, 2014
    Manufacturer
    SEKISUI DIAGNOSTICS, LLC
    Product Code
    JHI
    PMA / PMN Number
    K043385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2014 AND A URINE SAMPLE TESTED NEGATIVE USING THE OSOM COMBO TEST KIT. A KIDNEY X-RAY WAS PERFORMED AND AN ULTRASOUND REQUESTED. NO HCG CONFIRMATORY TESTING WAS PERFORMED. THE PATIENT PRESENTED THE NEXT DAY, (B)(6) 2014, IN THE EMERGENCY ROOM COMPLAINING OF "BLEEDING AND BEING IN PAIN FOR 4 DAYS." THE PATIENT WAS DIAGNOSED WITH A "RUPTURED ECTOPIC PREGNANCY." LAPAROSCOPIC LEFT SIDE SALPINGECTOMY WAS PERFORMED TO REMOVE 1 FALLOPIAN TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212296 124 OSOM COMBO HCG 25T KIT HCG TEST JHI SEKISUI DIAGNOSTICS, LLC 131519

    Patients

    Seq Age Sex Outcome Treatment
    1 Other