BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVIEW HCG DEV(URINE)20T

    MDR report key: 19590577 · Received June 22, 2024

    Report

    Report Number
    3005641941-2024-00004
    Event Type
    Malfunction
    Date Received
    June 22, 2024
    Date of Event
    May 31, 2024
    Report Date
    July 15, 2024
    Manufacturer
    ABON BIOPHARM (HANGZHOU) CO., LTD.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    1. BASED ON THE CURRENT COMPLAINT INFORMATION, NO PATIENT INFO WAS SHARED AND NO NEGATIVE IMPACT. HOWEVER, CONSIDERING FALSE POSTIVE OF HCG WOULD BE LIKE TO CONTRIBUTE TO A SERIOUS INJURY, THIS MDR IS BEING SUBMITTED CONSERVATIVELY. 2. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, CLEARVIEW HCG CASSETTE (25 MIU/ML), MARKETED IN AUSTRIA, WHICH IS SIMILAR TO HCG ONE STEP PREGNANCY DEVICE URINE MARKETED IN THE US UNDER 510(K) K993317.

    Additional Manufacturer Narrative · 0

    1. BASED ON THE CURRENT COMPLAINT INFORMATION, NO PATIENT INFO WAS SHARED AND NO NEGATIVE IMPACT. HOWEVER, CONSIDERING FALSE POSTIVE OF HCG WOULD BE LIKE TO CONTRIBUTE TO A SERIOUS INJURY, THIS MDR IS BEING SUBMITTED CONSERVATIVELY. 2. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT,CLEARVIEW HCG CASSETTE (25 MIU/ML), MARKETED IN AUSTRIA, WHICH IS SIMILAR TO HCG ONE STEP PREGNANCY DEVICE URINE MARKETED IN THE US UNDER 510(K) K993317.

    Description of Event or Problem · 0

    CS FORWARDED CUSTOMERS COMPLAINT ABOUT FALSE POSITIVE AND INVALID CLEARVIEW HCG DEV(URINE)20T, ITEM 4557942173 WITH BATCH NUMBER 0000809921.

    Description of Event or Problem · 0

    CS FORWARDED CUSTOMERS COMPLAINT ABOUT FALSE POSITIVE AND INVALID CLEARVIEW HCG DEV(URINE) 20T, ITEM 4557942173 WITH BATCH NUMBER 0000809921.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115413 CLEARVIEW HCG DEV(URINE)20T VISUAL, PREGNANCY HCG, PRESCRIPTION USE JHI ABON BIOPHARM (HANGZHOU) CO., LTD. 0000809921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown