MAUDE Adverse Event Report: WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO., LTD CLARISSE ONE STEP HCG PREGNANCY TEST; KIT,TEST ,,PREGNANCY ,HCG,OVER THE COUNTER

Model Number	N/A
Medical Device Problem Codes	Defective Device (2588); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: CLARISSE ONE STEP HCG PREGNANCY TEST
• Common Device Name: KIT,TEST ,,PREGNANCY ,HCG,OVER THE COUNTER
• Manufacturer (Section D): WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO., LTD; room 401-402, building b,; innovation base,no. 213-3,; weihai, shandong 26420 5; CH 264205
• Manufacturer (Section G): WEIHAI KANGZHOU BIOTECHNOLOGY ENGINEERING CO., LTD; room 401-402, building b,; innovation base,no. 213-3,; weihai, shandong 26420 5; CH 264205
• Manufacturer Contact: yu zhang ; room 401-402, building b,; innovation base,no. 213-3,; weihai, shandong ; CH
• MDR Report Key: 22563505
• Report Number: 3014171027-2025-00002
• Device Sequence Number: 18446507
• Product Code: LCX
• UDI-Device Identifier: 00808829125672
• UDI-Public: (01)00808829125672
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1901
• Device Explanted Year: 1901
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: 241110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Hispanic