MAUDE Adverse Event Report: LUMIRADX UK LTD. LUMIRADX SARS-COV-2 AG TEST STRIP KIT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number L016000101048

Device Problem Output Problem (3005)

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

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

This is report 1 of 2 for this facility and aware date.The customer reported a suspected false (incorrect) positive result from a rapid result covid test system on an individual asymptomatic patient.Confirmatory testing of the patient via polymerase chain reaction (pcr) testing was negative.No further action is deemed necessary at this time, as this event does not contribute to a significant deviation from the established performance characteristics of the product.

Event Description

This is report 1 of 2 for this facility and aware date.The customer reported a suspected false (incorrect) positive result from a rapid result covid test system on an individual asymptomatic patient.

• Brand Name: LUMIRADX SARS-COV-2 AG TEST STRIP KIT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): LUMIRADX UK LTD.; dumyat business park; alloa, FK10 2PB; UK FK10 2PB
• Manufacturer Contact: tim blicharz ; 221 crescent street; 5th floor; waltham, MA 02453 ; 6176219775
• MDR Report Key: 11473981
• MDR Text Key: 243814367
• Report Number: 3012642695-2021-00229
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2021

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
• Device Catalogue Number: L016000101048
• Device Lot Number: 6000142
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1