FDA Adverse Event
Other
Summary report: N
CLINITEK STATUS ANALYZER
MDR report key: 1918167
·
Received December 2, 2010
Report
- Report Number
- 1217157-2010-00036
- Event Type
- Other
- Date Received
- December 2, 2010
- Date of Event
- November 11, 2010
- Report Date
- November 11, 2010
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
- Product Code
- LCX
- PMA / PMN Number
- K031947
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE STATUS INSTRUMENT IS CAPABLE OF ACCEPTING AND MEASURING REFLECTANCE FROM TWO DIFFERENT SAMPLE FORMATS, EITHER STANDARD URINE TEST STRIPS OR CLINITEST HCG CASSETTES. CUSTOMER REPORTED THAT THEY OBSERVED A URINE TEST STRIP STUCK INSIDE THE INSTRUMENT. A TEST STRIP STUCK INSIDE THE STATUS INSTRUMENT MAY AFFECT RESULTS BY BLOCKING THE READ WINDOW. INSTRUMENT TAKEN OUT OF SERVICE AND SENT BACK TO MFR FOR EVAL.
Description of Event or Problem · 1
FIVE FALSE POSITIVE HCGS WERE REPORTED ON CLINITEK STATUS INSTRUMENT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLINITEK STATUS ANALYZER | CLINITEK STATUS ANALYZER | LCX | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. | CT STATUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |