FDA Adverse Event
Malfunction
Summary report: N
QT MICRO SYSTEM
MDR report key: 6348655
·
Received February 20, 2017
Report
- Report Number
- MW5067980
- Event Type
- Malfunction
- Date Received
- February 20, 2017
- Date of Event
- February 20, 2017
- Report Date
- February 20, 2017
- Manufacturer
- Q.I. MEDICAL, INC.
- Product Code
- LHI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PHARMACY TECHNICIAN OPENED QT MICRO SYSTEM CATALOG #TM6000, LOT# B16-2279, EXP. 02/2021 AND THE WHITE CAP WAS MISSING FROM THE PACKAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126525 | QT MICRO SYSTEM | QT MICRO SYSTEM | LHI | Q.I. MEDICAL, INC. | B16-2279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |