FDA Adverse Event
Other
Summary report: N
RAPIDLAB 1265
MDR report key: 1589404
·
Received January 25, 2010
Report
- Report Number
- 1217157-2010-00003
- Event Type
- Other
- Date Received
- January 25, 2010
- Date of Event
- January 12, 2010
- Report Date
- January 12, 2010
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
- Product Code
- GKR
- PMA / PMN Number
- K020616
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT LABELING INSTRUCTS CUSTOMERS TO WEAR PERSONAL PROTECTIVE EQUIPMENT INCLUDING SAFETY GLASSES TO PREVENT ACCIDENTAL CONTAMINATION.
Description of Event or Problem · 1
CUSTOMER REPORTS THAT WHILE THE UPPER DOOR OF THE INSTRUMENT WAS OPENED DURING A CARTRIDGE CHANGE AND SUBSEQUENT INITIALIZATION, THE CO-OXIMETER TUBING ATTACHED TO THE MANIFOLD DISENGAGED AND THE CONTENTS SPLASHED INTO THE OPERATOR'S EYE. THE OPERATOR RECEIVED A (B)(6) SHOT AND THERE ARE NO KNOWN ADVERSE EFFECTS FROM THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAPIDLAB 1265 | RAPIDLAB 1265 | GKR | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. | 1265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |