INTELISWAB COVID-19 RAPID TEST
Report
- Report Number
- 3004142665-2022-00005
- Event Type
- Malfunction
- Date Received
- January 6, 2022
- Date of Event
- December 17, 2021
- Report Date
- January 6, 2022
- Manufacturer
- ORASURE TECHNOLOGIES INC.
- Product Code
- QKP
- PMA / PMN Number
- EUA210378
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
(B)(4), REGULATORY MANAGER AT ORASURE TECHNOLOGIES INC., RECEIVED AN EMAIL FROM (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 INTO THE CALL CENTER TO REPORT FP RESULT. NO FOLLOW UP IS TO BE EXPECTED WITH THE COMPLAINT FILE AND THE INCIDENT WILL BE CLOSED INTERNALLY.
(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 (B)(4) HAS BEEN OPENED FOR PAST AND FUTURE FP CASES.
CONSUMER REPORTED TO THE CALL CENTER THAT THEY RECEIVED A POSITIVE RESULT USING INTELISWAB TEST KIT WHEN A PCR TEST SHOWED NEGATIVE RESULTS. CONSUMER SUBMITTED VOLUNTARY MDR#MW5106167 AND COMMENTED ON TWO ORASURE TECHNOLOGIES, INC. (B)(6) POSTS STATING THE BELOW: (B)(6) 2021: BEWARE, I AM A NURSE. USED THIS BRAND. GOT TWO DIFFERENT RESULTS, ONE "INCONCLUSIVE" AND ONE A FALSE POSITIVE! AFTER I GOT THE POSITIVE ON THIS HOME TEST, I WENT TO A LAB FOR TRUE RESULTS. I AM, IN FACT, NEGATIVE. DONT WASTE YOUR MONEY. TRYING TO GET A REFUND NOW FOR SHODDY LAB TESTING KIT. (B)(6) 2021: I AM A REGISTERED NURSE. BOUGHT THIS. BOTH TESTS WRONG! FIRST ONE "INCONCLUSIVE" WITH A PARTIAL LINE, SECOND ONE POSITIVE. WENT TO LAB FOR TESTING IMMEDIATELY, I AM NEGATIVE FOR COVID. TWO WRONG RESULTS IS HORRIBLE FOR A MEDICAL SUPPLIER. WHEN I CALLED TO REQUEST REFUND, THEY TOLD ME I HAVE TO TAKE PICTURES, UPLOAD AND SEND PICTURES TO PROVE! I TOLD HER I DONT KNOW HOW TO DO THAT. WE WILL SEE WHAT HAPPENS. REALLY SURPRISED THAT A COMPANY CAN DO THIS.
CONSUMER REPORTED TO THE CALL CENTER THAT THEY RECEIVED A POSITIVE RESULT USING INTELISWAB TEST KIT WHEN A PCR TEST SHOWED NEGATIVE RESULTS. CONSUMER SUBMITTED VOLUNTARY MDR#MW5106167 AND COMMENTED ON TWO ORASURE TECHNOLOGIES, INC. (B)(6) POSTS STATING THE BELOW: ON (B)(6) 2021: BEWARE, I AM A NURSE. USED THIS BRAND. GOT TWO DIFFERENT RESULTS, ONE "INCONCLUSIVE" AND ONE A FALSE POSITIVE! AFTER I GOT THE POSITIVE ON THIS HOME TEST, I WENT TO A LAB FOR TRUE RESULTS. I AM, IN FACT, NEGATIVE. DONT WASTE YOUR MONEY. TRYING TO GET A REFUND NOW FOR SHODDY LAB TESTING KIT. ON (B)(6) 2021: I AM A REGISTERED NURSE. BOUGHT THIS. BOTH TESTS WRONG! FIRST ONE "INCONCLUSIVE" WITH A PARTIAL LINE, SECOND ONE POSITIVE. WENT TO LAB FOR TESTING IMMEDIATELY, I AM NEGATIVE FOR COVID. TWO WRONG RESULTS IS HORRIBLE FOR A MEDICAL SUPPLIER. WHEN I CALLED TO REQUEST REFUND, THEY TOLD ME I HAVE TO TAKE PICTURES, UPLOAD AND SEND PICTURES TO PROVE! I TOLD HER I DONT KNOW HOW TO DO THAT. WE WILL SEE WHAT HAPPENS. REALLY SURPRISED THAT A COMPANY CAN DO THIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1183061 | INTELISWAB COVID-19 RAPID TEST | INTELISWAB | QKP | ORASURE TECHNOLOGIES INC. | 0006685141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female |