MAUDE Adverse Event Report: QUIDEL CORPORATION QUIDEL QUICKVUE AT HOME COVID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 1493200

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

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

Event Date 06/18/2022

Event Type  malfunction  

Event Description

Good morning.I have been routinely using at-home covid tests since they became widely available.I always follow the instructions carefully, but there is one brand of home test (quidel) that i always test positive on -- even if i test negative on another brand of home test or negative on a pcr the same day.I have documented this over and over again for the past year (12+ times).It is confusing and i am wondering if i am the only person to be experiencing this.I assume these are false positives, but my doctor is not sure why i test positive so consistently.I don't think that is an issue with the lot or improper storage.I have split a box of these tests with friends, but everyone else tests negative when i test positive.To my knowledge i have not actually had covid (i have always tested negative on other brands of home tests and pcrs).If there is currently anyone studying occurrences of false positive results for this brand, i would be very interested in connecting with them.Thank you.Reference report: mw5116859, mw5116860, mw5116861, mw5116862, mw5116863, mw5116864, mw5116865.

• Brand Name: QUIDEL QUICKVUE AT HOME COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 16787055
• MDR Text Key: 313825635
• Report Number: MW5116866
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• 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: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1493200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2023
• Patient Sequence Number: 1
• Treatment: MULTIVITAMIN
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White