BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUPID® HCG

    MDR report key: 7649880 · Received June 29, 2018

    Report

    Report Number
    7649880
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    June 6, 2018
    Report Date
    June 27, 2018
    Manufacturer
    STANBIO LABORATORY, L.P.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    PATIENT SCHEDULED APPOINTMENT FOR REMOVAL AND REINSERTION OF AN INTRAUTERINE DEVICE (IUD). PER PROTOCOL, PREGNANCY TEST CONDUCTED. AT THE 3 MINUTE (TIMED) MOMENT PER MANUFACTURER INSTRUCTIONS, THE TEST WAS CHECKED FOR SIGN OF POSITIVE. BOTH NURSE AND PROVIDER CONFIRMED TEST WAS NEGATIVE. MEDICAL ASSISTANT AT APPROXIMATELY THE 6-7 MIN POINT SAW A POSITIVE, INFORMED THE PROVIDER AND DECISION MADE TO DO A SECOND TEST PRIOR TO INSERTION. SECOND TEST CONFIRMED POSITIVE AT 3 MIN. QUANT HUMAN CHORIONIC GONADOTROPIN (HCG) ALSO CAME BACK AT 40. MANUFACTURER GUIDANCE STATES SENSITIVE TO HCG OF 20. INTERVIEWING OF STAFF NOTED THAT "YES, WE HAVE SEEN DELAYS LATELY, WITH POSITIVE SHOWING NOT TILL 4-5 MIN."

    Description of Event or Problem · 1

    PATIENT SCHEDULED APPOINTMENT FOR REMOVAL AND REINSERTION OF AN INTRAUTERINE DEVICE (IUD). PER PROTOCOL, PREGNANCY TEST CONDUCTED. AT THE 3 MINUTE (TIMED) MOMENT PER MANUFACTURER INSTRUCTIONS, THE TEST WAS CHECKED FOR SIGN OF POSITIVE. BOTH NURSE AND PROVIDER CONFIRMED TEST WAS NEGATIVE. MEDICAL ASSISTANT AT APPROXIMATELY THE 6-7 MIN POINT SAW A POSITIVE, INFORMED THE PROVIDER AND DECISION MADE TO DO A SECOND TEST PRIOR TO INSERTION. SECOND TEST CONFIRMED POSITIVE AT 3 MIN. QUANT HUMAN CHORIONIC GONADOTROPIN (HCG) ALSO CAME BACK AT 40. MANUFACTURER GUIDANCE STATES SENSITIVE TO HCG OF 20. INTERVIEWING OF STAFF NOTED THAT "YES, WE HAVE SEEN DELAYS LATELY, WITH POSITIVE SHOWING NOT TILL 4-5 MIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493740 QUPID® HCG VISUAL, PREGNANCY HCG, PRESCRIPTION USE JHI STANBIO LABORATORY, L.P. 1220-050 180221-556

    Patients

    Seq Age Sex Outcome Treatment
    1 9490 DA