MAUDE Adverse Event Report: CVS HEALTH EARLY RESULT PREGNANCY TEST; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Catalog Number 000233-12 9/21

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, i purchased cvs health early result pregnancy test, 2 test sticks.My 16 y.O.Daughter must show a negative pregnancy result test in order to start the 30-days ipledge program to use accutane.After urinating on the absorbent tip and followed the package instruction, both sticks gave an invalid result because no line appears in the control window.I returned to cvs and purchased another box of the same brand, again 2 sticks resulted in invalid.Both boxes that were purchased have lot no.: 10121496.Expire date=2025-11-30.Cvs health does not have a consumer product complain online nor a phone number to contact.Reference report #mw5115492, #mw5115493, #mw5115494.

• Brand Name: CVS HEALTH EARLY RESULT PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• MDR Report Key: 16501339
• MDR Text Key: 310910067
• Report Number: MW5115495
• Device Sequence Number: 1
• Product Code: LCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/04/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 000233-12 9/21
• Device Lot Number: 10121496
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian