MAUDE Adverse Event Report: PROCTOR & GAMBLE / SPD SWISS PRECISION DIAGNOSTICS GMBH C O PROCTER & GAMBLE CLEARBLUE DIGITAL PREGNANCY TEST; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Lot Number 0202937249

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2020

Event Type  malfunction  

Event Description

Over the past two days, i have used a total 4 different pregnancy tests from (b)(4) (digital, count-down 2 packs) and received errors on all tests.I followed the directions by putting the test in urine for 20 seconds, setting the test down flat, and i keep getting an error.I called today to alert the company and they stated the fda mandates i ship the tests back to them to issue a refund as their replacements are taking several days to ship out, which is not an option.This is false information.(b)(4) is mandated to report issues with their product to the fda but they are informing customers that the fda requires the products in order to issue a refund.This is an internal policy, not an fda requirement and completely misleading to customers.This pertains to lot number 0202937249 with expiration date 2023-06-30.When i stated this to the customer service person, she said i need to speak with a manager and they will call me back within 24 hours.Fda safety report id# (b)(4).

• Brand Name: CLEARBLUE DIGITAL PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• Manufacturer (Section D): PROCTOR & GAMBLE / SPD SWISS PRECISION DIAGNOSTICS GMBH C O PROCTER & GAMBLE
• MDR Report Key: 11071928
• MDR Text Key: 223748927
• Report Number: MW5098522
• Device Sequence Number: 1
• 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: 12/22/2020
• 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 Expiration Date: 06/30/2023
• Device Lot Number: 0202937249
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 65