FDA Adverse Event
Malfunction
Summary report: N
DIMENSION EXL WITH LM
MDR report key: 2884052
·
Received December 21, 2012
Report
- Report Number
- 1226181-2012-00173
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 26, 2012
- Report Date
- December 3, 2012
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC
- Product Code
- JJE
- PMA / PMN Number
- K944093
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SUPPORT CENTER (TSC). THE INCIDENT HAPPENED WHILE THE OPERATOR WAS EMPTING CUVETTES FROM A WASTE CONTAINER INTO A WASTE BIN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.
Description of Event or Problem · 1
AN OPERATOR WAS SPLASHED IN HER FACE WHILE EMPTYING A WASTE CONTAINER ON A DIMENSION EXL WITH LM INSTRUMENT . THE OPERATOR WASHED HER FACE IMMEDIATELY. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT INCLUDING LABORATORY COAT, GLOVES AND GLASSES. THE OPERATOR DID NOT NEED MEDICAL TREATMENT. THERE ARE NO KNOWN REPORTS OF STAFF INJURY OR DAMAGED PROPERTY DUE TO THE SPLASH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIMENSION EXL WITH LM | CLINICAL CHEMISTRY ANALYZER | JJE | SIEMENS HEALTHCARE DIAGNOSTICS INC | DIMENSION EXL WITH LM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |