BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSI HCG COMBO

    MDR report key: 2100902 · Received May 19, 2011

    Report

    Report Number
    MW5020655
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    March 30, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    LCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RADIOLOGIST REPORTED ON (B)(6) 2011 AFTER READING AN US DONE ON A 9 WEEK PREGNANT PT, THAT PT HAD AN ABDOMINAL CT DONE FOR ABDOMINAL PAIN ON (B)(6) 2011. URINE PREGNANCY TEST WAS NEGATIVE WHICH MEANT THAT PT WAS PREGNANT DURING CT A LITTLE OVER A WEEK. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MSI HCG COMBO URINE PREGNANCY TEST KIT LCX MERIDIAN BIOSCIENCE INC. 1158-1 08101566

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR