FDA Adverse Event
Other
Summary report: N
DCA 2000 SYSTEM FOR HBA1C
MDR report key: 1112203
·
Received August 6, 2008
Report
- Report Number
- 1217157-2008-00008
- Event Type
- Other
- Date Received
- August 6, 2008
- Date of Event
- July 14, 2008
- Report Date
- July 14, 2008
- Manufacturer
- BAYER CORP.
- Product Code
- LCP
- PMA / PMN Number
- K951361
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT IS BEING REPORTED BECAUSE IT OCCURRED IN A POTENTIALLY BIOHAZARDOUS ENVIRONMENT.
Description of Event or Problem · 1
CUSTOMER CUT THUMB WHILE ATTEMPTING TO REMOVE A JAMMED (B) (6) CARTRIDGE FROM THE DCA 2000 INSTRUMENT. THE EMPLOYEE WASHED AND BANDAGED THE CUT. A MATERIAL SAFETY DATA SHEET WAS PROVIDED UPON REQUEST. THE OCCUPATIONAL HEALTH DEPARTMENT AT THE REPORTING FACILITY PROVIDED INSTRUCTIONS CONCERNING CARE OF THE LACERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DCA 2000 SYSTEM FOR HBA1C | DCA 2000 | LCP | BAYER CORP. | 5031C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |