FDA Adverse Event
Injury
Summary report: N
THERASCREEN EGFR RGQ PCR KIT
MDR report key: 9845345
·
Received March 17, 2020
Report
- Report Number
- 3004013603-2020-00002
- Event Type
- Injury
- Date Received
- March 17, 2020
- Report Date
- March 17, 2020
- Manufacturer
- QIAGEN GMBH
- Product Code
- OWD
- UDI-DI
- 04053228002062
- PMA / PMN Number
- P120022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH NO INJURY WAS REPORTED, A FALSE POSITIVE RESULT REPORTED TO THE PHYSICIAN COULD CAUSE INJURY TO THE PATIENT. QIAGEN IS REPORTING THIS INCIDENT IN AN ABUNDANCE OF CAUTION. QIAGEN DOES NOT KNOW HOW THE RESULT WAS USED TO GUIDE THE PATIENT'S TREATMENT OR THE STATUS OF THE PATIENT.
Description of Event or Problem · 1
CUSTOMER OBTAINED A FALSE POSITIVE G719X RESULT USING THE TEST AND REPORTED IT TO THE PHYSICIAN. TREATMENT AND STATUS OF PATIENT UNKNOWN. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 305126 | THERASCREEN EGFR RGQ PCR KIT | THERASCREEN EGFR RGQ PCR KIT | OWD | QIAGEN GMBH | 1 | 163035334 | 04053228002062 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |