MAUDE Adverse Event Report: LUMIRADX UK LTD. LUMIRADX SARS-COV-2 RNA STAR COMPLETE; LUMIRADX SARS-COV-2 RNA STAR COMPLETE (EUA) KIT, 96

Catalog Number L018180130096

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

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

Customer reports observing false positive results in multiple runs with kit m2200940 & m2200948 of lumiradx sars-cov-2 rna star complete.

Manufacturer Narrative

Customer reported observing false positive results on multiple runs, when using lot#: m2200940 (exp: 10 jul 2023) & m2200948 (exp: 02 aug 2023).Field applications team worked with customer to troubleshoot the issue.Troubleshooting confirmed that amplicon contamination was the cause of the false positive results.Issue could not be recreated with retained units from the same lots.Customer was informed of best practice and decontamination procedures.No further issues were reported.Patient status was not reported.No patient harm, injury or adverse health consequences were communicated by the customer to lumiradx for the reported event.

• Brand Name: LUMIRADX SARS-COV-2 RNA STAR COMPLETE
• Type of Device: LUMIRADX SARS-COV-2 RNA STAR COMPLETE (EUA) KIT, 96
• Manufacturer (Section D): LUMIRADX UK LTD.; unit 50; yorkshire way; doncaster, south yorkshire DN33F T; UK DN33FT
• Manufacturer Contact: carol adiletto-francis ; 221 crescent street; 5th floor; waltham, MA 02453 ; 6176249775
• MDR Report Key: 16400339
• MDR Text Key: 310097964
• Report Number: 3012642695-2023-00006
• Device Sequence Number: 1
• Product Code: QJR
• UDI-Device Identifier: 05060537715353
• UDI-Public: 5060537715353
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2023
• Device Catalogue Number: L018180130096
• Device Lot Number: M2200940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1