BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDS Q.S., HCG SERUM/URINE

    MDR report key: 380121 · Received February 27, 2002

    Report

    Report Number
    2024674-2002-00001
    Event Type
    Other
    Date Received
    February 27, 2002
    Date of Event
    January 23, 2002
    Report Date
    February 27, 2002
    Manufacturer
    QUIDEL CORP
    Product Code
    JHI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP ALLEGED THAT PT TESTED NEGATIVE FOR HCG WITH URINE SPECIMEN IN 2002. PT ADMITTED FOR HYSTERECTOMY ON THE FOLLOWING DAY. THE PHYSICIAN WAS NOTIFED OF A PREGNANCY (APPROX TEN WEEKS) BY THE PATHOLOGY REPORT (UNKNOWN DATE). A POST OPERATION SERUM BETA SUB HCG WAS TESTED TWO DAYS AFTER SURGERY. THE LEVEL WAS 14,098 MIU/ML HCG. NO OTHER PT INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDS Q.S., HCG SERUM/URINE IMMUNOASSAY FOR THE QUAL. DETECTION OF HCG. JHI QUIDEL CORP 00179 0113611

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other