MAUDE Adverse Event Report: INVERNESS MEDICAL, LLC EQUATE PREGNANCY TEST; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2021

Event Type  malfunction  

Event Description

I took an equate pregnancy test and received a false positive.After doing some research, it seems that many women have experienced the same, resulting in emotional trauma.Fda safety report id # (b)(4).

• Brand Name: EQUATE PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• Manufacturer (Section D): INVERNESS MEDICAL, LLC
• MDR Report Key: 11273148
• MDR Text Key: 230585335
• Report Number: MW5099188
• 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: 01/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 107