FDA Adverse Event
Malfunction
Summary report: N
FLOWFLEX COVID-19 ANTIGEN HOME TEST
MDR report key: 20010790
·
Received August 21, 2024
Report
- Report Number
- 2531491-2024-00084
- Event Type
- Malfunction
- Date Received
- August 21, 2024
- Date of Event
- August 5, 2024
- Report Date
- August 19, 2024
- Manufacturer
- ACON LABORATORIES, INC.
- Product Code
- QKP
- PMA / PMN Number
- EUA210494
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE CURRENT COMPLAINT IS PENDING INVESTIGATION FROM OUR CONTRACT MANUFACTURER, AND WE WILL PROVIDE FOLLOW UP MDR UPON INVESTIGATION COMPLETION SUCH AS REVIEW OF BATCH RECORDS OR TESTING OF RETENTION SAMPLES. ANY ADDITIONAL INFORMATION RECEIVED BY ACON MAY BE PROVIDED TO FDA IN A FOLLOW UP MDR.
Description of Event or Problem · 0
INVALID RESULT. CUSTOMER REPORTED THAT NO LINES APPEARED IN THE CT WELL AND SHE PUT THE SAMPLE IN THE S WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2353028 | FLOWFLEX COVID-19 ANTIGEN HOME TEST | ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP | QKP | ACON LABORATORIES, INC. | COV3090006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |