MAUDE Adverse Event Report: SURE-AID PREGNANCY TEST; KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Lot Number 006182

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

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

Event Date 05/14/2019

Event Type  malfunction  

Event Description

Pregnancy test invalid.Both times.First box showed no result, blank.Serial no: (b)(4); second turned on almost immediately and went invalid after a few seconds:(b)(4).Second serial number is: (b)(4) and matching numbers on both.Lot no: 006182, "exp mr2021." exclusively distributed by (b)(4).Name of the company that makes (or compounds) the product: insight pharmaceutical, llc.Reason for use: late period.Quantity: 2 sticks.How was it taken or used? pee on stick.

• Brand Name: SURE-AID PREGNANCY TEST
• Type of Device: KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
• MDR Report Key: 8620041
• MDR Text Key: 145617479
• Report Number: MW5086711
• Device Sequence Number: 2
• 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: Other
• Type of Report: Initial
• Report Date: 05/14/2019
• 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: 03/01/2021
• Device Lot Number: 006182
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1