ELLUME COVID-19 HOME TEST
Report
- Report Number
- 3014862-2021-00013
- Event Type
- Malfunction
- Date Received
- December 2, 2021
- Date of Event
- October 19, 2021
- Report Date
- December 21, 2021
- Manufacturer
- ELLUME LIMITED
- Product Code
- QKP
- PMA / PMN Number
- EUA203011
- Removal / Correction Number
- 88801
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
REPORT REQUIRED BY THE FDA FOR EUA. EUA (B)(4). INVESTIGATION NOT COMPLETE AT TIME OF REPORT. FOLLOW UP REPORT TO FOLLOW COMPLETION OF INVESTIGATION. RELATES TO (B)(6) (3014862188-2021-00012, TEST 1 OF 2). THIS IS A RETROSPECTIVE REPORT DUE TO CHALLENGES IMPLEMENTING ESG.
REPORT REQUIRED BY THE FDA FOR EUA. (B)(4). IN SECTION B5, REPORTER INADVERTENTLY DID NOT NOTE THAT 2 FALSE POSITIVES WERE REPORTED BY USER. RELATES TO ((B)(4), TEST 1 OF 2).
REPORT REQUIRED BY THE FDA FOR EUA. (B)(4). INVESTIGATION NOT COMPLETE AT TIME OF REPORT. ADDITIONAL FOLLOW UP REPORT TO FOLLOW COMPLETION OF INVESTIGATION. RELATES TO C4438 (3014862188-2021-00012, TEST 1 OF 2). THIS IS A RETROSPECTIVE REPORT DUE TO CHALLENGES IMPLEMENTING ESG CORRECTED DATA: INITIAL REPORT IS CANCELLED DUE TO AN ERROR IN MFR NUMBER. REPORT WILL BE SUBMITTED UNDER THE CORRECTED REPORT NUMBER (3014862188-2021-00013) (10 DIGIT FEI-BASED).
USER REPORTED FALSE POSTIVE RESULT. FOLLOW UP TESTING NOT SPECIFIED. REPORT 2 OF 2.
USER REPORTED 2 FALSE POSITIVE RESULTS. FOLLOW UP TESTING NOT SPECIFIED. REPORT 2 OF 2.
USER REPORTED FALSE POSITIVE RESULT. FOLLOW UP TESTING NOT SPECIFIED. REPORT 2 OF 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1818830 | ELLUME COVID-19 HOME TEST | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM, PRODUCT CODE: QKP, | QKP | ELLUME LIMITED | PF05Q-H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |