FDA Adverse Event
Malfunction
Summary report: N
FLOWFLEX COVID-19 ANTIGEN HOME TEST
MDR report key: 20011879
·
Received August 21, 2024
Report
- Report Number
- 2531491-2024-00075
- Event Type
- Malfunction
- Date Received
- August 21, 2024
- Date of Event
- July 26, 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 RELATED TO PERFORMANCE ISSUE OR DEVICE MALFUNCTION, BUT NO INFORMATION WAS PROVIDED FOR ACON TO CONDUCT AN INVESTIGATION. ANY ADDITIONAL INFORMATION RECEIVED BY ACON MAY BE PROVIDED TO FDA IN A FOLLOW UP MDR.
Description of Event or Problem · 0
FALSE NEGATIVE RESULT (S). CUSTOMER STATED THAT HIS FAMILY OF 6 ALL USED THE COVID TESTS TWICE AT DIFFERENT TIMES AND THEY ALL CAME BACK NEGATIVE FOR COVID. THEY WENT TO THE DOCTOR'S OFFICE AND GOT TESTED, IT CAME BACK POSITIVE FOR COVID. THE TESTS EITHER GAVE ALL 6 OF US FALSE POSITIVES ON 12 TESTS, OR THEY'RE JUST GARBAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1007822 | FLOWFLEX COVID-19 ANTIGEN HOME TEST | ANTIGEN DIAGNOSTIC FOR SARS-COV-2, PRODUCT CODE: QKP | QKP | ACON LABORATORIES, INC. | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |