BEUDAMED
    FDA Adverse Event Summary report: N

    IMMUNOCARD STAT HCG COMBO

    MDR report key: 2116544 · Received May 26, 2011

    Report

    Report Number
    2116544
    Date Received
    May 26, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MERIDIAN BIOSCIENCE, INC.
    Product Code
    JHI
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THREE DIFFERENT PHYSICIAN PRACTICES THAT UTILIZE THE SAME IN-OFFICE PREGNANCY TEST HAVE REPORTED CONCERNS OVER THE VALIDITY OF THE TEST RESULTS. ONE OFFICE REPORTED "AT LEAST" TWO CASES IN WHICH PATIENTS REPORTED POSITIVE AT-HOME PREGNANCY TESTS, BUT THE IN-OFFICE TEST RESULTED AS NEGATIVE. BOTH WOMEN WERE TOLD THAT THEY WERE NOT PREGNANT, TOOK ANOTHER AT-HOME PREGNANCY TEST THAT WERE AGAIN POSITIVE. THEY INFORMED THE OFFICE WHO DID LAB HCG (HUMAN CHORIONIC GONADOTROPIN) TEST WHICH RESULTED AS POSITIVES IN BOTH CASES. ANOTHER PHYSICIAN PRACTICE REPORTED "AT LEAST" TWO CASES IN WHICH THE PATIENTS REPORTED POSITIVE AT-HOME PREGNANCY TESTS. THE IN-OFFICE PREGNANCY TEST DID NOT RESULT FOR OVER TEN MINUTES AND THE RESULT WAS "VERY, VERY FAINT" OR DIFFICULT TO READ. THE OFFICE IS CALLING THESE RESULTS "SLIGHTLY POSITIVE". THE HCG TEST PERFORMED BY THE OFFICE RESULTED AS POSITIVE. THE PHYSICIAN AT THAT PRACTICE FELT THE HCG WAS SO ELEVATED THAT THE TEST SHOULD HAVE IMMEDIATELY RESULTED AS POSITIVE. THEY HAVE REMOVED THESE TESTS FROM USE. ONE PRACTICE RETURNED BOTH TESTS (USED) TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER RESPONDED THAT THEY DID NOT DETECT ANY PROBLEMS. THE THIRD PRACTICE HAD SIMILAR ISSUES; HOWEVER, I DO NOT HAVE THE NUMBER OF AFFECTED PATIENTS/OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMUNOCARD STAT HCG COMBO IMMUNOCARD STAT HCG COMBO JHI MERIDIAN BIOSCIENCE, INC. * 08101464, 0810113

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR