FDA Adverse Event
Other
Summary report: N
CENTRICITY TRIWIN LABORATORY INFORMATION SYST
MDR report key: 772307
·
Received August 16, 2006
Report
- Report Number
- 9615148-2006-00001
- Event Type
- Other
- Date Received
- August 16, 2006
- Date of Event
- July 20, 2006
- Report Date
- July 20, 2006
- Manufacturer
- GE HEALTHCARE INTEGRATED IT SOLUTIONS
- Product Code
- JQP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORTED ISSUE IS CURRENTLY BEING INVESTIGATED. A FOLLOW UP REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION OR TESTING RESULTS BECOME AVAILABLE.
Description of Event or Problem · 1
GE HEALTHCARE DETECTED A PRODUCT ISSUE WITH THE CENTRICITY LABORATORY INFORMATION SYSTEM. THE HEMATOLOGY MODULE IS GENERATIONG TEST DATA FOR TESTS THAT HAVE NOT BEEN RUN. TEST RESULTS FOR "CELLS META, MYELO, PROMY, BLASTS ATL LYMPHS, OTHER ETC" ARE REPORTING AS "0" WHEN THE USER DID NOT ENTER OR REQUEST THIS INFORMATION TO BE ON THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRICITY TRIWIN LABORATORY INFORMATION SYST | JQP | JQP | GE HEALTHCARE INTEGRATED IT SOLUTIONS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |