FDA Adverse Event
Malfunction
Summary report: N
INTELISWAB COVID-19 RAPID TEST
MDR report key: 12924625
·
Received December 3, 2021
Report
- Report Number
- 3004142665-2021-00016
- Event Type
- Malfunction
- Date Received
- December 3, 2021
- Date of Event
- November 28, 2021
- Report Date
- November 29, 2021
- Manufacturer
- ORASURE TECHNOLOGIES INC.
- Product Code
- QKP
- PMA / PMN Number
- EUA210378
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
CONSUMER POSTED A REVIEW ON (B)(6). NO FOLLOW UP IS TO BE EXPECTED WITH THE COMPLAINT FILE AND THE INCIDENT WILL BE CLOSED INTERNALLY.
Description of Event or Problem · 0
CONSUMER LEFT A REVIEW ONLINE AT (B)(6) STATING BOTH TESTS IN THE INTELISWAB KIT GAVE FALSE NEGATIVE RESULTS. CONSUMER ALSO STATED THE SWAB WAS ODD SHAPED AND ROUGH. (B)(6) REVIEW (B)(6) 2021: MY SON TOOK TWO OF THESE AND THEY WERE BOTH FALSE NEGATIVE AND THE SWAB IS ODD SHAPED AND ROUGH.
Description of Event or Problem · 0
CONSUMER LEFT A REVIEW ONLINE AT (B)(6) STATING BOTH TESTS IN THE INTELISWAB KIT GAVE FALSE NEGATIVE RESULTS. CONSUMER ALSO STATED THE SWAB WAS ODD SHAPED AND ROUGH. (B)(6) REVIEW (B)(6) 2021: MY SON TOOK TWO OF THESE AND THEY WERE BOTH FALSE NEGATIVE AND THE SWAB IS ODD SHAPED AND ROUGH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1819880 | INTELISWAB COVID-19 RAPID TEST | INTELISWAB | QKP | ORASURE TECHNOLOGIES INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |