BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDS Q.S. HCG SERUM/URINE

    MDR report key: 328142 · Received April 20, 2001

    Report

    Report Number
    2024674-2001-00001
    Event Type
    Injury
    Date Received
    April 20, 2001
    Date of Event
    March 23, 2001
    Report Date
    April 20, 2001
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    JHI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO ER IN 2001 WITH SEVERE ABDOMINAL PAIN. PREGNANCY TEST WAS NEGATIVE PER NURSE. ULTRASOUND SHOWED MASS. DOCTOR DIAGNOSED PT WITH POSSIBLE CYST. PT TREATED AND SENT HOME. PT RETURNED 5 DAYS LATER WITH SEVERE ABDOMINAL PAIN. PREGNANCY TEST WAS POSITIVE. ULTRASOUND SHOWED MASS. PT ADMITTED TO SURGERY. PT'S FALLOPIAN TUBE HAD RUPTURED DUE TO ECTOPIC PREGNANCY. SERUM FROM INITIAL SAMPLE WAS TESTED WITH 2ND SAMPLE, 5 DAYS LATER BOTH QUALITATIVELY (METHOD UNK) AND QUANTITATIVELY (RIA). BOTH WERE POSITIVE WITH HCG LEVEL AT 5,709 (UNITS OF MEASURE UNK). QUANTITATIVE TEST WITH SAMPLE FROM 2ND SAMPLE SHOWED THAT HCG LEVEL WAS LOWER THAN FIRST SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18310 CARDS Q.S. HCG SERUM/URINE IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HCG JHI QUIDEL CORPORATION 00179 0100241

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention