FDA Adverse Event
Malfunction
Summary report: N
ELLUME COVID-19 HOME TEST
MDR report key: 13082655
·
Received December 23, 2021
Report
- Report Number
- 3014862188-2021-02162
- Event Type
- Malfunction
- Date Received
- December 23, 2021
- Date of Event
- September 3, 2021
- Report Date
- December 9, 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
Additional Manufacturer Narrative · 0
REPORT REQUIRED BY FDA FOR EUA. INVESTIGATION NOT COMPLETE AT TIME OF REPORT. FOLLOW-UP REPORT TO FOLLOW COMPLETION OF INVESTIGATION. RELATES TO (B)(4) (3014862188-2021-02160, 2: TESTS 1, 2, OF 3). THIS IS A RETROSPECTIVE REPORT DUE TO CHALLENGES IMPLEMENTING ESG.
Description of Event or Problem · 0
USER REPORTED 3 FALSE POSITIVE RESULTS. NO ADDITIONAL INFORMATION RELATING TO FOLLOW-UP TESTING WAS PROVIDED. THIS IS REPORT 3 OF 3.
Description of Event or Problem · 0
USER REPORTED 3 FALSE POSITIVE RESULTS. NO ADDITIONAL INFORMATION RELATING TO FOLLOW-UP TESTING WAS PROVIDED. THIS IS REPORT 3 OF 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1969422 | ELLUME COVID-19 HOME TEST | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM | QKP | ELLUME LIMITED | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |