inforMED
MalfunctionLCX

CLARISSE ONE STEP HCG PREGNANCY TEST

Received Jul 22, 2025 · Event occurred Jun 10, 2025

Report 3014171027-2025-00001 · MDR key 22563469

Device

Generic name

Kit , Test , Pregnancy ,hcg,over The Counter

Model number

N/A

Catalog number

N/A

Lot number

241110

Product problems

  • Defective Device
  • Activation, Positioning or Separation Problem
  • Defective Device
  • Activation, Positioning or Separation Problem

Patient

24 YR · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

I HAVE 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 HAVE 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,"DID NOT YOU CALL YESTERDAY?''. I EXPLAINED THE SITUATION AND MENTIONED THE SECOND TEST ALSO DID NOT WORK. HE TOLD ME "SHOULD NOT BE BUYING MORE " AND LITERALLY HUNG UP ONE ME. IT WAS SO UNPROFESSIONAL AND HONESTLY MADE ME FEEL STUPID FOR EVEN BOTHERING TO REACH OUT . I AM NOT ABOUT TO WALK INTO DOLLAR TREE WITH A USED TEST IN HAND JUST TO PROVE A POINT , BUT I HAVE RELIED ONE 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 AM 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 ARE JUST TRYING TO TAKE CARE OF YOUR HEALTH. I HAVE ALREADY CONTACTED DOLLAR TREE'S CUSTOMER SUPPORT AS WELL AS THE STORE REPRESENTATIVE I SPOKE WITH WAS DISMISSIVE AND ENDED THE PRODUCT PERFORMANCE OF PROVIDE A RESOLUTION. BECAUSE OF THIS , I AM NOW SEEKING ALTERNATIVE SUPPORT OF GUIDANCE,AS I WENT TO ENSURE MY CONCERNS ARE ACKNOWLEDGED AND ADDRESSED APPROPRIATELY . PATIENT CODE : 4582 . DEVICE CODE : 2588,1506. REFERENCE REPORT : MW5171742.

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.

Remedial action

  • Other