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

Model Number 20402

Device Problems No Apparent Adverse Event (3189); Erratic Results (4059)

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

Event Date 08/12/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: a review of the dhr found that the lot met all release criteria.A review of complaint history did not identify any adverse trends.Root cause: unable to determine.Source: phone.

Event Description

Reported discrepant sars results for 1 consumer.It is unknown if the consumer was symptomatic.The consumer communicated that over the previous couple of months, they had tested positive with quickvue otc and negative with another brand's rapid antigen assay.5 additional consumer events were also communicated which are captured on separate reports.

• Brand Name: QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: QUICKVUE AT-HOME OTC COVID-19 TEST
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar ct.; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar ct.; san diego, CA 92121 ; 7405893382
• MDR Report Key: 15324254
• MDR Text Key: 303416196
• Report Number: 0002024674-2022-09700
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 20402
• Device Catalogue Number: 20402
• Device Lot Number: F40541
• Date Manufacturer Received: 08/12/2022
• 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