FDA Adverse Event
Malfunction
Summary report: N
INTELISWAB COVID-19 RAPID TEST
MDR report key: 16456258
·
Received February 28, 2023
Report
- Report Number
- 3004142665-2023-00017
- Event Type
- Malfunction
- Date Received
- February 28, 2023
- Date of Event
- February 10, 2023
- Report Date
- February 28, 2023
- Manufacturer
- ORASURE TECHNOLOGIES, INC.
- Product Code
- QKP
- PMA / PMN Number
- EUA210378
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE CONSUMER POSTED A COMMENT ON AN INTELISWAB FACEBOOK POST. THE CONSUMER DID NOT PROVIDE A LOT NUMBER OR OTHER PRODUCT INFORMATION. ORASURE TECHNOLOGIES, INC. IS UNABLE TO CONTACT THE CONSUMER DIRECTLY AS NO CONTACT INFORMATION WAS PROVIDED. NO ADDITIONAL FOLLOW UP IS TO BE EXPECTED WITH THIS COMPLAINT AND THE INCIDENT WILL BE CLOSED INTERNALLY.
Description of Event or Problem · 0
CONSUMER LEFT A COMMENT ON AN ORASURE TECHNOLOGIES, INC. FACEBOOK POST CLAIMING FALSE NEGATIVE RESULTS. FACEBOOK COMMENT LISA BAKER 'MY DAUGHTER HAD IT AND TESTED NEGATIVE.'
Description of Event or Problem · 0
CONSUMER LEFT A COMMENT ON AN ORASURE TECHNOLOGIES, INC. FACEBOOK POST CLAIMING FALSE NEGATIVE RESULTS. FACEBOOK COMMENT LISA BAKER 'MY DAUGHTER HAD IT AND TESTED NEGATIVE.'
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61049 | INTELISWAB COVID-19 RAPID TEST | INTELISWAB | QKP | ORASURE TECHNOLOGIES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |