FDA Adverse Event
Malfunction
Summary report: Y
CLIP COVID RAPID ANTIGEN TEST
MDR report key: 14690720
·
Received June 14, 2022
Report
- Report Number
- 3015104453-2022-00026
- Event Type
- Malfunction
- Date Received
- June 14, 2022
- Date of Event
- January 12, 2022
- Report Date
- June 14, 2022
- Manufacturer
- LUMINOSTICS, INC DBA CLIP HEALTH
- Product Code
- QKP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
TEST DATA REVIEW: ANALYSIS OF FIELD DATA FOR LOT CC-10148-A PERFORMED IN (B)(6) 2022 SHOWED THAT THE MEAN TEST-LINE VALUE OF THE FIELD NEGATIVES MATCHED THE MEAN VALUE OF IN-HOUSE BUFFER NEGATIVES TO WITHIN SPECIFICATIONS. PRODUCT IS PERFORMING AS EXPECTED.
Description of Event or Problem · 0
OUT OF 85 RUN, 2 THAT TESTED POSITIVE, RETESTED, AND CAME BACK NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1658169 | CLIP COVID RAPID ANTIGEN TEST | SARS-COV-2 ANTIGEN TEST | QKP | LUMINOSTICS, INC DBA CLIP HEALTH | MDL001, CLIP ANALYZER AND MDL002, CLIP COVID RAPID ANTIGEN TEST KIT | CC-10148-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |