FDA Adverse Event
Other
Summary report: N
CLINITEK STATUS+ ANALYZER
MDR report key: 2090861
·
Received May 5, 2011
Report
- Report Number
- 1217157-2011-00013
- Event Type
- Other
- Date Received
- May 5, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 15, 2011
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS, MFG LTD.
- Product Code
- LCX
- PMA / PMN Number
- K091216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INSTRUMENT WAS CHECK VISUALLY. CALIBRATION BAR AND MIRROR WERE CLEAN AND APPEARED FREE OF SPLASHES/STAINS. INSTRUMENT IS PERFORMING ACCEPTABLY.
Description of Event or Problem · 1
PT WAS TESTED IN A&E ((B)(4) 2011 8:35 PM) AND THE ANALYZER GAVE A POSITIVE HCG. NO UNNECESSARY MEDICAL PROCEDURE WAS PERFORMED. NO TREATMENT WAS WITHHELD AS A RESULT OF THIS INCIDENT. THERE WAS NO IMPACT TO PT HEALTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLINITEK STATUS+ ANALYZER | CLINITEK STATUS+ ANALYZER | LCX | SIEMENS HEALTHCARE DIAGNOSTICS, MFG LTD. | CT STATUS+ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |