BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARISSE ONE STEP HCG PREGNANCY TEST

    MDR report key: 22563505 · Received July 22, 2025

    Report

    Report Number
    3014171027-2025-00002
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 10, 2025
    Report Date
    June 11, 2025
    Manufacturer
    WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO., LTD
    Product Code
    LCX
    UDI-DI
    00808829125672
    PMA / PMN Number
    K183097
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETAINED SAMPLES FROM THE COMPLAINED BATCH WITH LOT NUMBER # 241110 HAVE BEEN EXAMINED. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS AND DESIGN INTENT. PRODUCTION RECORDS FOR THIS BATCH HAVE ALSO BEEN REVIEWED. NO NONCONFORMITIES WERE FOUND. ADDITIONALLY, IT WAS CHECKED WHETHER THERE WERE ANY OTHER CUSTOMER COMPLAINTS FOR THIS BATCH, AND IT WAS CONFIRMED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    I'VE USED DOLLAR TREE PREGNANCY TESTS ON AND OFF FOR ABOUT 3 YEARS AND NEVER HAD ANY ISSUES UNTIL NOW. RECENTLY, I BOUGHT ONE AND IT COMPLETELY FAILED LIKE NO CONTROL LINE, TOTALLY UNUSABLE. FIGURED IT MIGHT'VE BEEN A DUD, SO I WENT BACK AND GRABBED ANOTHER. SAME THING HAPPENED AGAIN. I DECIDED TO CALL THE NUMBER ON THE PACKAGE (WWW.DELTABRANDS.COM) TO REPORT IT, JUST TO LET THEM KNOW. THE GUY WHO ANSWERED WAS SUPER DISMISSIVE RIGHT FROM THE START AND SAID, "DIDN'T YOU CALL YESTERDAY?". I EXPLAINED THE SITUATION AND MENTIONED THE SECOND TEST ALSO DIDN'T WORK. HE TOLD ME I "SHOULDN'T BE BUYING MORE" AND LITERALLY HUNG UP ON ME. IT WAS SO UNPROFESSIONAL AND HONESTLY MADE ME FEEL STUPID FOR EVEN BOTHERING TO REACH OUT. I'M NOT ABOUT TO WALK INTO DOLLAR TREE WITH A USED TEST IN HAND JUST TO PROVE A POINT, BUT I'VE RELIED ON THESE FOR YEARS BECAUSE THEY WERE ALWAYS AFFORDABLE AND ACCURATE. WITH HOW HARD IT IS TO GET A DOCTOR'S APPOINTMENT QUICKLY, THESE TESTS HAVE BEEN A GO-TO FOR ME. I'M CURRENTLY KEEPING A CLOSE EYE ON THINGS AND GETTING BLOOD DRAWN AT (B)(6) JUST TO BE SAFE, BUT IT REALLY SUCKS TO FEEL DISMISSED WHEN YOU'RE JUST TRYING TO TAKE CARE OF YOUR HEALTH. I?VE ALREADY CONTACTED DOLLAR TREE'S CUSTOMER SUPPORT AS WELL AS THE STORE DIRECTLY REGARDING THIS ISSUE, BUT UNFORTUNATELY, NEITHER WAS ABLE TO ASSIST ME. THE SUPPORT REPRESENTATIVE I SPOKE WITH WAS DISMISSIVE AND ENDED THE CALL ABRUPTLY, AND THE LOCAL STORE INFORMED ME THEY'RE UNABLE TO PROCESS ANY CONCERNS RELATED TO PRODUCT PERFORMANCE OR PROVIDE A RESOLUTION. BECAUSE OF THIS, I'M NOW SEEKING ALTERNATIVE SUPPORT OR GUIDANCE, AS I WANT TO ENSURE MY CONCERNS ARE ACKNOWLEDGED AND ADDRESSED APPROPRIATELY. PATIENT CODE:4582. DEVICE CODE:2588,1506. REFERENCE REPORT: MW5171743.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574221 CLARISSE ONE STEP HCG PREGNANCY TEST KIT,TEST ,,PREGNANCY ,HCG,OVER THE COUNTER LCX WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO., LTD N/A 241110 00808829125672

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female