FDA Adverse Event
Malfunction
Summary report: N
IHEALTH
MDR report key: 23812620
·
Received December 15, 2025
Report
- Report Number
- 3008573045-2025-00058
- Event Type
- Malfunction
- Date Received
- December 15, 2025
- Date of Event
- November 19, 2025
- Report Date
- December 5, 2025
- Manufacturer
- ANDON MEDICAL CO.,LTD
- Product Code
- QKP
- PMA / PMN Number
- K233842
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
1.CUSTOMER TESTED NEGATIVE USING THE IHEALTH COVID-19 ANTIGEN RAPID TEST, THEN TESTED POSITIVE AT THE HOSPITAL. 2. TEST REPORT FROM HOSPITAL HAS TITLE "COVID-19 ANTIGEN, MANUAL",EXPLAIN THE ANTIGEN TESTING DONE.THE CUSTOMER HAS NOT INDICATED THAT HE HAD A PCR CONFIRMATION OF HIS COVID DIAGNOSIS. 3. THE MANUFACTURER RETESTED THE LOT (255CO10919) POSITIVE SAMPLES,NO FALSE NEGATIVE WERE DETECTED.
Description of Event or Problem · 0
CUSTOMER TESTED NEGATIVE USING THE IHEALTH COVID-19 ANTIGEN RAPID TEST, THEN TESTED POSITIVE AT THE HOSPITAL, THEN TESTED NEGATIVE AGAIN USING THE IHEALTH COVID-19 ANTIGEN RAPID TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1662789 | IHEALTH | Coronavirus antigen detection test system. | QKP | ANDON MEDICAL CO.,LTD | ICO-3000 | 255CO10919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |