FDA Adverse Event
Other
Summary report: N
IMMULITE 2000
MDR report key: 1613111
·
Received February 5, 2010
Report
- Report Number
- 2247117-2010-00003
- Event Type
- Other
- Date Received
- February 5, 2010
- Date of Event
- January 6, 2010
- Report Date
- January 6, 2010
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS INC.
- Product Code
- DGC
- PMA / PMN Number
- K970227
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR INSTRUMENT EVAL. AFTER EVAL OF THE INSTRUMENT, THE FSE REPLACED THE CO2 SCRUBBER, AND THE CO2 SCRUBBER TUBING, AND DECONTAMINATED THE SYS WITH NAOH AND WATER. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
DISCORDANT LOW AFP RESULTS WERE OBTAINED ON A PT SAMPLE. THE INITIAL DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON THE SAME DAY. THE REPEAT RESULT WAS NOT REPORTED TO THE PHYSICIAN. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMULITE 2000 | IMMUNO-ASSAY | DGC | SIEMENS HEALTHCARE DIAGNOSTICS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |