FDA Adverse Event
Malfunction
Summary report: N
INTELISWAB COVID-19 RAPID TEST
MDR report key: 15487342
·
Received September 26, 2022
Report
- Report Number
- 3004142665-2022-00030
- Event Type
- Malfunction
- Date Received
- September 26, 2022
- Date of Event
- September 25, 2022
- Report Date
- September 26, 2022
- 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
CONSUMER POSTED A COMMENT ON FACEBOOK.COM WITH NO PERSONAL INFORMATION. NO ADDITIONAL FOLLOW UP IS TO BE EXPECTED WITH THE COMPLAINT FILE, AND THE INCIDENT WILL BE CLOSED INTERNALLY.
Description of Event or Problem · 0
THE FOLLOWING COMMENT WAS LEFT ON AN ORASURE TECHNOLOGIES, INC. INTELISWAB FACEBOOK POST: (B)(6). 'MY HOME TEST WRONG BOTH TIMES SAID NEGATIVE AND I HAD IT'.
Description of Event or Problem · 0
THE FOLLOWING COMMENT WAS LEFT ON AN ORASURE TECHNOLOGIES, INC. INTELISWAB FACEBOOK POST: (B)(6). 'MY HOME TEST WRONG BOTH TIMES SAID NEGATIVE AND I HAD IT'.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2303820 | INTELISWAB COVID-19 RAPID TEST | INTELISWAB | QKP | ORASURE TECHNOLOGIES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |