FDA Adverse Event
Malfunction
Summary report: N
SOFT PATH
MDR report key: 670024
·
Received January 26, 2006
Report
- Report Number
- 1058332-2006-00003
- Event Type
- Malfunction
- Date Received
- January 26, 2006
- Report Date
- March 7, 2002
- Manufacturer
- SCC SOFT COMPUTER
- Product Code
- LNX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RECURRENCE OF 1058332-2006-00002. THIS EVENT WAS A RECURRENCE OF USER FACILITY REPORTED SOFTWARE FAILURE IN WHICH THE DIAGNOSIS TEXT FROM ONE CASE WAS MERGED INTO ANOTHER PT'S CASE. THE USER FAILED TO LOAD DELIVERED CORRECTION TO THE LIVE SYSTEM. THE CORRECTION WAS EVENTUALLY MOVED TO THE LIVE SYSTEM IN 3/2002.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFT PATH | LAB INFO SYSTEM | LNX | SCC SOFT COMPUTER | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |