FDA Adverse Event
Malfunction
Summary report: N
CENTRICITY TRIWIN LABORATORY INFORMATION SYSTEM
MDR report key: 1105247
·
Received August 8, 2008
Report
- Report Number
- 9615148-2008-00004
- Event Type
- Malfunction
- Date Received
- August 8, 2008
- Date of Event
- July 11, 2008
- Report Date
- July 11, 2008
- Manufacturer
- GE HEALTHCARE INFORMATION TECHNOLOGIES
- Product Code
- MMH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN VIEWING RESULTS IN PATIENT VIEWER (A DISPLAY FUNCTION WITHIN THE SOFTWARE APPLICATION) AND A COAGULATION RESULT IS OUTSIDE OF A LINEARITY LIMIT (HIGH OR LOW), THEN ALL OF THE RESULTS PROCESSED AFTER THIS WILL SHOW THE SAME RESULT AS THE RESULT WITH THE OUT OF LINEARITY LIMIT. IT WAS REPORTED THAT PRINTED REPORTS DISPLAY ACCURATE LAB VALUES. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRICITY TRIWIN LABORATORY INFORMATION SYSTEM | LABORATORY INFORMATION SYSTEM | MMH | GE HEALTHCARE INFORMATION TECHNOLOGIES | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |