MAUDE Adverse Event Report: UNKNOWN WALGREENS ANALOG PREGNANCY TEST; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Model Number 172214

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2020

Event Type  malfunction  

Event Description

I used two walgreens company non digital pregnancy tests, both gave a false positive.After researching online it seems most or all of these tests give a false positive.This has caused numerous people to experience great heartbreak.Despite complaints, walgreens has refused to pull the product from the shelves.Fda safety report id # (b)(4).

• Brand Name: WALGREENS ANALOG PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10829512
• MDR Text Key: 216642491
• Report Number: MW5097811
• Device Sequence Number: 2
• Product Code: LCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/07/2020
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 172214
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Weight: 56