MAUDE Adverse Event Report: LUMIRADX UK LTD. LUMIRADX RNA COV-2 STAR COMPLETE

Catalog Number L018180530096

Device Problem Output Problem (3005)

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

Event Date 02/08/2022

Event Type  malfunction  

Event Description

Customer complained about positive samples, every sample of this lot was positive.They thought it was contamination, so they cleaned the whole lab, still same issue.New lot number was better and no "false" positive samples occured.Qc release testing indicated no issues with lot.Lot m2100176 batch records reviewed as part of initial investigation and no issues to note.Qc release testing indicated no issues with lot.Customer did not provide any further details despite multiple requests.No further information to add.

Manufacturer Narrative

Customer complained about positive samples, every sample of this lot was positive.They thought it was contamination, so they cleaned the whole lab, still same issue.New lot number was better and no "false" positive samples occured.Customer did not indicate if any patient samples were scored falsely.Further details and information were requested from customer site but no response has been received.Patient staus was not reported.No patient harm, injury or adverse health consequences were comunicated by the customer to lumiradx for the reported event.

• Brand Name: LUMIRADX RNA COV-2 STAR COMPLETE
• Type of Device: LUMIRADX RNA COV-2 STAR COMPLETE
• Manufacturer (Section D): LUMIRADX UK LTD.; unit 50; yorkshire way; doncaster, south yorkshire DN33F T; UK DN33FT
• Manufacturer Contact: tim blicharz ; 221 crescent street; 5th floor; waltham, MA 02453 ; 6176219775
• MDR Report Key: 14684357
• MDR Text Key: 301497903
• Report Number: 3012642695-2022-00109
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2022

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: L018180530096
• Device Lot Number: M2100176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1