INTELISWAB COVID-19 RAPID TEST
Report
- Report Number
- 3004142665-2022-00008
- Event Type
- Malfunction
- Date Received
- January 13, 2022
- Date of Event
- January 6, 2022
- Report Date
- January 13, 2022
- Manufacturer
- ORASURE TECHNOLOGIES INC.
- Product Code
- QKP
- PMA / PMN Number
- EUA210378
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(6) , REGULATORY MANAGER AT ORASURE TECHNOLOGIES INC., RECEIVED AN EMAIL FROM (B)(6) PH.D, STAFF FELLOW WITH THE FDA REQUESTING THAT ALL FALSE POSITIVE CASES OF INTELISWAB BE REPORTED TO THE FDA AS AN MDR IN ACCORDANCE WITH 21 CFR PART 803. PREVIOUSLY ORASURE TECHNOLOGIES WAS NOT SUBMITTING FP CASES AS AN MDR AS IT WAS A NON-REPORTABLE EVENT, THEREFORE PDR- 22-0002 HAS BEEN OPENED FOR PAST AND FUTURE FP CASES.
(B)(6) RECEIVED AN EMAIL FROM (B)(6) PH.D, STAFF FELLOW WITH THE FDA REQUESTING THAT ALL FALSE POSITIVE CASES OF INTELISWAB BE REPORTED TO THE FDA AS AN MDR IN ACCORDANCE WITH 21 CFR PART 803. PREVIOUSLY ORASURE TECHNOLOGIES WAS NOT SUBMITTING FP CASES AS AN MDR AS IT WAS A NON-REPORTABLE EVENT, THEREFORE (B)(4) HAS BEEN OPENED FOR PAST AND FUTURE FP CASES.
(B)(4), STAFF FELLOW WITH THE FDA REQUESTING THAT ALL FALSE POSITIVE CASES OF INTELISWAB BE REPORTED TO THE FDA AS AN MDR IN ACCORDANCE WITH 21 CFR PART 803. PREVIOUSLY ORASURE TECHNOLOGIES WAS NOT SUBMITTING FP CASES AS AN MDR AS IT WAS A NON-REPORTABLE EVENT, THEREFORE (B)(4) HAS BEEN OPENED FOR PAST AND FUTURE FP CASES. (B)(6) 2022- CONSUMER CALLED LEFT AN INQUIRY ON INTELISWAB.COM, AND THE CALL CENTER FOLLOWED UP WITH THE CONSUMER TO OBTAIN MORE INFORMATION REGARDING THE FALSE POSITIVE. THE INCIDENT WILL BE CLOSED INTERNALLY.
CONSUMER LEFT AN INQUIRY ON INTELISWAB.COM STATING THEY RECEIVED A FALSE POSITIVE RESULT USING INTELISWAB. CONSUMER HAD PERFORMED ANOTHER RAPID TEST, AS WELL AS HAD A PCR TEST PERFORMED THE SAME DAY AS RECEIVING THE POSITIVE INTELISWAB RESULT, AND BOTH RAPID AND PCR TEST WERE NEGATIVE. INTELISWAB.COM INQUIRY HELLO. I AM REPORTING A POTENTIAL FALSE POSITIVE RECEIVED USING INTELLISWAB COVID 19 PART NO. 300-3516, LOT 0006688590. PERSON HAD MILD SYMPTOMS (WATERY EYES, THROAT ACHE, BODY ACHE, CONGESTED NOSE, NO FEVER, NO LOSS OF TASTE) BUT TESTED NEGATIVE ON THE SAME DAY WITH A SECOND RAPID TEST (GENBODY) AND PCR.
CONSUMER LEFT AN INQUIRY ON INTELISWAB.COM STATING THEY RECEIVED A FALSE POSITIVE RESULT USING INTELISWAB. CONSUMER HAD PERFORMED ANOTHER RAPID TEST, AS WELL AS HAD A PCR TEST PERFORMED THE SAME DAY AS RECEIVING THE POSITIVE INTELISWAB RESULT, AND BOTH RAPID AND PCR TEST WERE NEGATIVE. INTELISWAB.COM INQUIRY HELLO. I AM REPORTING A POTENTIAL FALSE POSITIVE RECEIVED USING INTELLISWAB COVID 19 PART NO. 300-3516, LOT 0006688590. PERSON HAD MILD SYMPTOMS (WATERY EYES, THROAT ACHE, BODY ACHE, CONGESTED NOSE, NO FEVER, NO LOSS OF TASTE) BUT TESTED NEGATIVE ON THE SAME DAY WITH A SECOND RAPID TEST (GENBODY) AND PCR.
CONSUMER LEFT AN INQUIRY ON INTELISWAB.COM STATING THEY RECEIVED A FALSE POSITIVE RESULT USING INTELISWAB. CONSUMER HAD PERFORMED ANOTHER RAPID TEST, AS WELL AS HAD A PCR TEST PERFORMED THE SAME DAY AS RECEIVING THE POSITIVE INTELISWAB RESULT, AND BOTH RAPID AND PCR TEST WERE NEGATIVE. INTELISWAB.COM INQUIRY HELLO. I AM REPORTING A POTENTIAL FALSE POSITIVE RECEIVED USING INTELLISWAB COVID 19 PART NO. 300-3516, LOT 0006688590. PERSON HAD MILD SYMPTOMS (WATERY EYES, THROAT ACHE, BODY ACHE, CONGESTED NOSE, NO FEVER, NO LOSS OF TASTE) BUT TESTED NEGATIVE ON THE SAME DAY WITH A SECOND RAPID TEST (GENBODY) AND PCR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1674114 | INTELISWAB COVID-19 RAPID TEST | INTELISWAB | QKP | ORASURE TECHNOLOGIES INC. | 0006688590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Prefer Not To Disclose |