FDA Adverse Event
Other
Summary report: N
IMMULITE 2000
MDR report key: 1506826
·
Received October 13, 2009
Report
- Report Number
- 2247117-2009-00039
- Event Type
- Other
- Date Received
- October 13, 2009
- Date of Event
- September 30, 2009
- Report Date
- October 1, 2009
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTIS INC.
- Product Code
- CEW
- PMA / PMN Number
- K970227
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS HEALTHCARE TECHNICAL SUPPORT ENGINEER (TSE) ANALYZED THE INSTRUMENT DATA AND DETERMINED THAT THE CAUSE OF THE DISCORDANT RESULT WAS DUE TO A SAMPLE LEVEL SENSE ERROR. THE CAUSE OF THE SAMPLE LEVEL SENSE ERROR WAS POSSIBLY DUE TO A BUBBLE IN THE SAMPLE TUBE. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.
Description of Event or Problem · 1
DISCORDANT INTACT PTH (IPT) RESULT WAS OBTAINED ON A PT SAMPLE, GENERATED ON AN IMMULITE 2000. THE SAMPLE WAS REPEATED AND THE RESULT WAS REPORTED. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT INTACT PTH (IPT) RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMULITE 2000 | IMMUNO-ASSAY ANALYZER | CEW | SIEMENS HEALTHCARE DIAGNOSTIS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |