inforMED
MalfunctionLCX

FIRST RESPONSE EARLY RESULT PREGNANCY TEST

Received Jun 2, 2025 · Event occurred May 21, 2025

Report MW5170937 · MDR key 22125878

Device

Generic name

Kit, Test, Pregnancy, Hcg, Over The Counter

Lot number

TE5007ER1

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings

Patient

31 YR · Female

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

I TOOK A FRER (FIRST RESPONSE EARLY DETECTION) PREGNANCY TEST WITH FIRST MORNING URINE ON (B)(6) 2025 (MID-STREAM) AND (B)(6) 2025 (DIPPED INTO CUP). BOTH SHOWED A PINK LINE IN THE TEST WINDOW. I TOOK A WONDFO TEST ON (B)(6) (DIPPED INTO CUP, FIRST MORNING URINE) AND IT WAS NEGATIVE. I TOOK A CLEAR BLUE DIGITAL 6 DAYS SOONER ON (B)(6) (DIPPED INTO CUP, FIRST MORNING URINE) AND IT WAS NEGATIVE. I GOT BLOODWORK DONE ON (B)(6) 2025, AND I AM NOT PREGNANT. DATE OF UNPROTECTED SEX WAS (B)(6) 2025.