FDA Adverse Event
Injury
Summary report: N
QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL
MDR report key: 10311876
·
Received July 22, 2020
Report
- Report Number
- 3004013603-2020-00004
- Event Type
- Injury
- Date Received
- July 22, 2020
- Date of Event
- June 11, 2020
- Report Date
- July 22, 2020
- Manufacturer
- QIAGEN GMBH
- Product Code
- QJR
- PMA / PMN Number
- EUA200075
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO INJURY WAS REPORTED. QIAGEN IS REPORTING THIS INCIDENT IN AN ABUNDANCE OF CAUTION AND IN ACCORDANCE WITH THE CONDITIONS OF APPROVAL UNDER THE EMERGENCY USE AUTHORIZATION FOR THIS PRODUCT.
Description of Event or Problem · 1
SUSPECTED FALSE POSITIVE RESULTS FOR INFLUENZA A (FLU A) WERE OBTAINED FOR 8 PATIENT SAMPLES BY THE CUSTOMER WITH THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL, MAT. 691223.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 775724 | QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL | REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | QJR | QIAGEN GMBH | 166023368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |