FDA Adverse Event
Malfunction
Summary report: N
QUICKVUE AT-HOME OTC COVID-19 TEST
MDR report key: 16400118
·
Received February 17, 2023
Report
- Report Number
- 0002024674-2023-00022
- Event Type
- Malfunction
- Date Received
- February 17, 2023
- Date of Event
- January 6, 2022
- Report Date
- February 17, 2023
- Manufacturer
- QUIDEL CORPORATION
- Product Code
- QKP
- UDI-DI
- 30014613339724
- PMA / PMN Number
- EUA210269
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
H10: CORRECTION TO MANUFACTURER NARRATIVE: INVESTIGATION CONCLUSION: NO ADVERSE TREND WAS IDENTIFIED FOR THIS LOT NUMBER FOR THE REPORTED ISSUE. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: PHONE.
Additional Manufacturer Narrative · 0
INVESTIGATION CONCLUSION: NO ADVERSE TREND WAS IDENTIFIED FOR THIS LOT NUMBER FOR THE REPORTED ISSUE. INVESTIGATION SUMMARY: IN RESPONSE TO YOUR COMPLAINT, WE REVIEWED THE COMPLAINT HISTORY LOG FOR THIS LOT AND NO SIGNIFICANT TREND WAS IDENTIFIED FOR THE REPORTED ISSUE. THE INFORMATION YOU PROVIDED HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED FOR FUTURE TRENDS. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: PHONE: (831) 319-7537.
Description of Event or Problem · 0
QQV SARS OTC: CUSTOMER REPORTED A SMALL AMOUNT OF BLOOD ON SWAB--TSS PROVIDED GUIDANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 167150 | QUICKVUE AT-HOME OTC COVID-19 TEST | QUICKVUE AT-HOME OTC COVID-19 TEST | QKP | QUIDEL CORPORATION | 20402 | NONE | 30014613339724 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |