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

Model Number 20402

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/23/2022

Event Type  malfunction  

Event Description

Qv sars otc: customer asked if blood would affect the results--tss requested additional information.Customer already took the test but did not have a bloody swab, they then used nasal spray and had bloody nose.

Manufacturer Narrative

Investigation conclusion: a review of the product did not find any unusual trend for the reported complaint category.Without a lot number, no further investigation can be conducted.Investigation summary: in response to your complaint, we performed a search for similar complaints of the reported problem.No adverse trend was observed.Without product lot information, no further testing could be conducted.Although we were unable to duplicate your complaint, the information you provided has been documented and will continue to be monitored.Root cause: insufficient info source: phone: (b)(6).

• 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 court; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar court; san diego, CA 92121 ; 7405893382
• MDR Report Key: 16061678
• MDR Text Key: 307725328
• Report Number: 0002024674-2022-10677
• Device Sequence Number: 1
• Product Code: QKP
• 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: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 20402
• Device Catalogue Number: 20402
• Device Lot Number: NONE
• Date Manufacturer Received: 12/23/2022
• 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