BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MBI HCG COMBO

    MDR report key: 2100901 · Received May 19, 2011

    Report

    Report Number
    MW5020654
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 8, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FEMALE PT CAME INTO THE ED COMPLAINING OF ABDOMINAL PAIN. WE DID A QUICK URINE PREGNANCY TEST WHICH CAME BACK NEGATIVE. FOLLOWING THE TEST, PT WAS TAKEN TO RADIOLOGY FOR A CT OF THE ABDOMEN. DURING THE TIME PT WAS IN CT, THE URINE TEST STARTED SHOWING POSITIVE; 30 MINS HAVE NOW ELAPSED. THE PT HAD HER CT WHICH SHOWED AN ECTOPIC PREGNANCY. PT REQUIRED SURGERY ANYWAY; NOT A VIABLE FETUS. BLOOD WAS SENT AND A QUANTITATIVE WAS DONE WHICH DID SHOW THE PT PREGNANT. DURING OUR INVESTIGATION, ANOTHER PT THAT HAD A NEGATIVE URINE TEST AND REQUIRED AN ABDOMINAL CT WAS (B)(6) PREGNANT. ANOTHER REPORT PENDING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBI HCG COMBO URINE HCG JHI MERIDIAN BIOSCIENCE INC. 1158-1 08101566

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR