FDA Adverse Event
Other
Summary report: N
DCA 2000 SYSTEM FOR HBA1C
MDR report key: 1416665
·
Received May 6, 2009
Report
- Report Number
- 1217157-2009-00012
- Event Type
- Other
- Date Received
- May 6, 2009
- Date of Event
- March 20, 2009
- Report Date
- April 8, 2009
- Manufacturer
- BAYER CORP.
- Product Code
- GKR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
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 REPORTED A LEAKING REAGENT CARTRIDGE. UPON REMOVING THE CARTRIDGE FROM THE INSTRUMENT, THE CUSTOMER NOTICED A HOLE IN THE BOTTOM OF THE CARTRIDGE AND LIQUID HAD LEAKED ONTO HIS HAND. CUSTOMER RETURNED CARTRIDGE FOR EVALUATION. THERE WAS NO IMPACT TO A PATIENT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DCA 2000 SYSTEM FOR HBA1C | DCA 2000 SYSTEM FOR HBA1C | GKR | BAYER CORP. | 2000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |