BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 24789678 · Received April 6, 2026

    Report

    Report Number
    24789678
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    February 9, 2026
    Report Date
    April 3, 2026
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    URINE PREGNANCY TEST CAME BACK FAINTLY POSITIVE. PATIENT WENT FOR BLOODWORK AFTER APPOINTMENT TO CONFIRM AND HCG WAS NEGATIVE. WHEN WE'VE BEEN READING THE PREGNANCY TEST AT 3 MINS, THERE IS FAINT LINE THAT IS PRESENT; THIS LINE TENDS TO FADE ~4 MINS. THE LOT NUMBER FOR ALL OF THESE TESTS IS 0000972721 & EXPIRATION IS 2/19/2027. EMAILED THE REP [REDACTED] TO NOTIFY OF THE EVENT INITIAL CONTACT FOR PRODUCT MFG/MODEL. MANUFACTURER RESPONSE FOR POINT OF CARE URINE PREGNANCY TEST, (BRAND NOT PROVIDED) (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283309 CARDINAL HEALTH VISUAL, PREGNANCY HCG, PRESCRIPTION USE JHI CARDINAL HEALTH 200, LLC B1077-22 0000972721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other