MAUDE Adverse Event Report: LUMIRADX LUMIRADX SARS-COV-2 AG; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem False Positive Result (1227)

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

Event Date 12/18/2020

Event Type  malfunction  

Event Description

I received a rapid covid 19 test on (b)(6) 2020 (lumiradx sars-cov-2 ag) from (b)(6).The result was positive so i got retested 24 hours later at the same (b)(6) but for a pcr test as well as a state-sponsored site for a second pcr test.Both pcr tests were negative, so i will conclude the rapid test result was a false positive.Fda safety report id# (b)(4).

• Brand Name: LUMIRADX SARS-COV-2 AG
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): LUMIRADX; 221 crescent street, 5th floor; waltham MA 02453
• MDR Report Key: 11100349
• MDR Text Key: 224768731
• Report Number: MW5098574
• Device Sequence Number: 1
• Product Code: QKP
• 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 Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 100