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

Lot Number TEST STRIP LOT NUMBER 6,000,17

Device Problem False Positive Result (1227)

Patient Problem Sore Throat (2396)

Event Date 04/22/2021

Event Type  malfunction  

Event Description

False positive rapid covid test result in fully vaccinated patient with mild cold symptoms.Test was performed at (b)(6) rapid testing site using lumiradx rapid test.I noted that the workspace where testing was being performed was quite full of other vials from patients immediately prior to me.I suspected a false positive as i was a month past full vaccination with moderna and was only experiencing a sore throat.Followed up with suspected false positive by re-test at another (b)(6) location for a pcr test the same day which returned negative results.Fda safety report id # (b)(4).

• Brand Name: LUMIRADX
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): LUMIRADX; 221 crescent st; waltham MA 02453
• MDR Report Key: 11737060
• MDR Text Key: 247995339
• Report Number: MW5101004
• 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: 04/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2021
• Device Lot Number: TEST STRIP LOT NUMBER 6,000,17
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 61