FDA Adverse Event
Malfunction
Summary report: N
ULTRA LABORATORY INFORMATION SYSTEM
MDR report key: 1076516
·
Received July 11, 2008
Report
- Report Number
- 9615148-2008-00003
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- June 3, 2008
- Report Date
- June 10, 2008
- Manufacturer
- GE HEALTHCARE INFORMATION TECHNOLOGIES
- Product Code
- MMH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ISSUE WAS DETERMINED TO BE CAUSED BY A CODE ERROR. THE RANGE FLAG FOR NUMERIC RESULTS WERE INCORRECTLY OVERWRITTEN.
Description of Event or Problem · 1
IT WAS REPORTED THAT LOW REFERENCE RANGE FLAGS WERE NOT REPORTED AS EXPECTED IN HL7 MESSAGES. THIS ISSUE WAS DISCOVERED IN THE CUSTOMER'S TEST ENVIRONMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRA LABORATORY INFORMATION SYSTEM | LABORATORY INFORMATION SYSTEM | MMH | GE HEALTHCARE INFORMATION TECHNOLOGIES | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |