FDA Adverse Event
Injury
Summary report: N
ACCESS 2 IMMUNOASSAY SYSTEM
MDR report key: 1911213
·
Received November 30, 2010
Report
- Report Number
- 2122870-2010-00825
- Event Type
- Injury
- Date Received
- November 30, 2010
- Date of Event
- November 8, 2010
- Report Date
- November 8, 2010
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- 922823/A007
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER WAS CLEANING THE ASPIRATE PROBES AS A PART OF MAINTENANCE PROCEDURE. THE CUSTOMER DID NOT HAVE SAFETY GLASSES OR GOGGLES ON AT THE TIME OF THE EVENT. ROOT CAUSE IS USER ERROR. INSTRUMENT NOT INVOLVED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO CONTRAD 70 SPLASHED INTO THE EYE DURING ASPIRATE PROBE CLEANING. THE CUSTOMERS EYE WAS RINSED AT AN EYE WASH STATION. NO OTHER INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCESS 2 IMMUNOASSAY SYSTEM | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | ACCESS 2 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |