MAUDE Adverse Event Report: QUIDEL CORP. QUIDEL; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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

Patient Problem Fever (1858)

Event Date 03/15/2021

Event Type  malfunction  

Event Description

My partner took a covid-19 test that showed she was negative.However, she is showing symptoms including a three day fever and is living in the same apartment as me.Who has tested positive for covid and i also am showing all of the symptoms.Fda safety report id # (b)(4).

• Brand Name: QUIDEL
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 11514731
• MDR Text Key: 241065963
• Report Number: MW5100075
• Device Sequence Number: 1
• Product Code: QKP
• 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: 03/15/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 54