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

Lot Number 1902254

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2019

Event Type  malfunction  

Event Description

I took the (b)(6) early result analog pregnancy test on two separate occasions and was shocked to see one faint and one dark line.Per the instructions contained in the test box, this indicates a positive test result.After contacting my doctor and confirming that i am not pregnant, i looked at the reviews on the (b)(6) website.This appears to be a chronic problem and users have experienced a positive test result when testing with water.(b)(6).

• Brand Name: WALGREENS EARLY RESULT ANALOG PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8471301
• MDR Text Key: 140774947
• Report Number: MW5085481
• Device Sequence Number: 1
• Product Code: LCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/27/2019
• 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: No Information
• Device Expiration Date: 01/31/2021
• Device Lot Number: 1902254
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR