FDA Adverse Event
Malfunction
Summary report: N
SOFTLAB
MDR report key: 669937
·
Received January 26, 2006
Report
- Report Number
- 1058332-2006-00010
- Event Type
- Malfunction
- Date Received
- January 26, 2006
- Report Date
- November 5, 2004
- Manufacturer
- SCC SOFT COMPUTER
- Product Code
- LNX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE CLIENT REQUESTED ASSISTANCE IN CREATING A NEW REPORT LAYOUT. DURING THE COURSE OF TESTING, THE CLIENT NOTICED THAT THE INCORRECT REFERENCE RANGES WERE BEING ASSIGNED TO TESTS. DURING SCC'S INVESTIGATION IT WAS DISCOVERED THAT AN OBSOLETE VARIABLE RELATED TO REFERENCE RANGES WAS COPIED INTO THE CLIENT'S NEWLY CUSTOMIZED REPORT LAYOUT. THIS PROBLEM CAN LEAD TO INCORRECT REFERENCE RANGES BEING APPLIED TO THE PT REPORT. THE PROBLEM WAS NOT WITH THE SOFTWARE, BUT WITH THE MANUAL COPYING OF AN OLDER REPORT LAYOUT VARIABLE INTO THE NEWLY CUSTOMIZED LAYOUT WHICH OVERWROTE THE CORRECT VARIABLE WITH THE OBSOLETE VARIABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFTLAB | LAB INFO SYSTEM | LNX | SCC SOFT COMPUTER | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |