FDA Adverse Event
Injury
Summary report: N
QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL
MDR report key: 10483257
·
Received September 2, 2020
Report
- Report Number
- 3004013603-2020-00013
- Event Type
- Injury
- Date Received
- September 2, 2020
- Date of Event
- August 5, 2020
- Report Date
- September 2, 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. THE SAMPLE RESULT HAD A CT >30. THE IFU INSTRUCTS USERS TO DO A CONFIRMATORY SPECIFICITY TEST FOR A CT>29. THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL HEALTHCARE PROVIDER FACT SHEET PUBLISHED ALONGSIDE THE IFU STATES LABORATORY TEST RESULTS SHOULD ALWAYS BE CONSIDERED IN THE CONTEXT OF CLINICAL OBSERVATIONS AND EPIDEMIOLOGICAL DATA IN MAKING A FINAL DIAGNOSIS AND PATIENT MANAGEMENT DECISIONS
Description of Event or Problem · 1
A SUSPECTED FALSE POSITIVE RESULT FOR BORDETELLA PERTUSSIS WAS OBTAINED FOR 2 PATIENT SAMPLES WITH THE QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL, MAT. 691223.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 947123 | QIASTAT-DX RESPIRATORY SARS-COV-2 PANEL | REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | QJR | QIAGEN GMBH | 200107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |