MAUDE Adverse Event Report: QUIDELORTHO CORPORATION QUICKVUE AT-HOME OTC COVID-19 TEST

Catalog Number 20402

Device Problems False Positive Result (1227); No Apparent Adverse Event (3189)

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

Event Date 12/25/2023

Event Type  malfunction  

Event Description

Customer reporting 1 false positive sars result.Customer states the result was negative when using another brand rapid antigen test.Through interview it was found the qv kit being used was expired more than 6 months.

Manufacturer Narrative

Investigation conclusion: a review of the dhr found that the reported lot expired on 07/14/23.Root cause: potentially related to expired product use source: phone.

• Brand Name: QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: QUICKVUE AT-HOME OTC COVID-19 TEST
• Manufacturer (Section D): QUIDELORTHO CORPORATION; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar court; san diego, CA 92121
• MDR Report Key: 18535182
• MDR Text Key: 333146235
• Report Number: 0002024674-2024-00082
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 30014613339724
• UDI-Public: 30014613339724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2024

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: Lay User/Patient
• Device Catalogue Number: 20402
• Device Lot Number: F41564
• Initial Date Manufacturer Received: 12/25/2023
• Initial Date FDA Received: 01/18/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1