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

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Event Description

Took quidel rapid covid test at (b)(6) hq on (b)(6) 2020 at approximately 8:30 am.Received positive test result.Took pcr test with quality first urgent care drive up testing site on (b)(6) at approximately 12 pm.Result returned on (b)(6) as negative.Fda safety report id# (b)(4).

• Brand Name: COVID RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 11100342
• MDR Text Key: 224769437
• Report Number: MW5098573
• Device Sequence Number: 1
• Product Code: QKP
• 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: 12/28/2020

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: 12/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 75