QUICKVUE AT-HOME OTC COVID-19 TEST
Report
- Report Number
- 0002024674-2021-00052
- Event Type
- Malfunction
- Date Received
- September 30, 2021
- Date of Event
- September 11, 2021
- Report Date
- September 30, 2021
- Manufacturer
- QUIDEL CORPORATION
- Product Code
- QKP
- PMA / PMN Number
- EUA210269
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
SUBJECT: QV SARS OTC - CHILD PUT REAGENT TUBE CAP INTO HIS MOUTH. REVIEWED SDS WITH CONSUMER AND RECOMMENDED TO CONTACT PHYSICIAN. INVESTIGATION CONCLUSION: NA. INVESTIGATION SUMMARY: TS REACHED OUT TFOR A WELL-CHECK NOTED THAT THEY ARE DOING FINE AND DO NOT REQUIRE ADDITIONAL SUPPORT ROOT CAUSE: CUSTOMER PROCEDURAL ERROR.
SUBJECT: QV SARS OTC - CHILD PUT REAGENT TUBE CAP INTO HIS MOUTH. REVIEWED SDS WITH CONSUMER AND RECOMMENDED TO CONTACT PHYSICIAN. INVESTIGATION CONCLUSION: NA. INVESTIGATION SUMMARY: TS REACHED OUT TFOR A WELL-CHECK NOTED THAT THEY ARE DOING FINE AND DO NOT REQUIRE ADDITIONAL SUPPORT. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR. FOLLOW-UP TO CHANGE PRODUCT CODE FROM QMN TO QKP (CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM).
FOLLOW-UP TO CORRECT THE PRODUCT CODE TO QKP.
QV SARS OTC - CHILD PUT REAGENT TUBE CAP INTO HIS MOUTH. REVIEWED SDS WITH CONSUMER AND RECOMMENDED TO CONTACT PHYSICIAN.
QV SARS OTC - CHILD PUT REAGENT TUBE CAP INTO HIS MOUTH. REVIEWED SDS WITH CONSUMER AND RECOMMENDED TO CONTACT PHYSICIAN.
QV SARS OTC - CHILD PUT REAGENT TUBE CAP INTO HIS MOUTH. REVIEWED SDS WITH CONSUMER AND RECOMMENDED TO CONTACT PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1456161 | QUICKVUE AT-HOME OTC COVID-19 TEST | QUICKVUE AT-HOME OTC COVID-19 TEST | QKP | QUIDEL CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |