MAUDE Adverse Event Report: QUIDEL CORPORATION QUEVUE ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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

Patient Problems Sore Throat (2396); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/22/2021

Event Type  malfunction  

Event Description

My daughter has taken 4 quidel quickvue antigen tests, they have all come back positive.Her tests had all had a tinge of blood on the swab tip.She has taken 3 rt pcr tests from 2 different pharmacies that have all come back negative.She's swabbed herself in my presence for all tests.Im at a loss of what is happening, i am following the test instructions to a t.Her pediatricians guidance is to isolate her and treat her as positive.She is eligible for the vaccine on her birthday (b)(6) and i am really confused by these test results.She had a sore throat, runny nose but pollen has been super high here.She has been running warm at night 99-100 but otherwise says she feels fine.Fda safety report id # (b)(4).

• Brand Name: QUEVUE ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 12561725
• MDR Text Key: 274486236
• Report Number: MW5104304
• Device Sequence Number: 3
• Product Code: QKP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/28/2021
• 4 Devices were Involved in the Event: 1 2 3 4

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 82