FDA Adverse Event
Other
Summary report: N
UF-100I SYSTEM MODULE
MDR report key: 2957252
·
Received February 6, 2013
Report
- Report Number
- 1217157-2013-00009
- Event Type
- Other
- Date Received
- February 6, 2013
- Date of Event
- December 5, 2012
- Report Date
- December 6, 2012
- Manufacturer
- DATA INNOVATIONS, INC.
- Product Code
- KQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A SIEMENS CUSTOMER SVC ENGINEER WAS DISPATCHED TO THE ACCOUNT. THE PROBLEM WAS RESOLVED BY RE-LOADING THE SOFTWARE AND CHANGING THE PURGE SETTING TO ELIMINATE OLD DATA.
Description of Event or Problem · 1
PT DEMOGRAPHICS AND TEST RESULTS WERE CORRECTLY REPORTED TO THE LIS, BUT THE PRINTED REPORTS REFLECTED DIFFERENT PT DEMOGRAPHICS. THERE WAS NO INJURY FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49511 | UF-100I SYSTEM MODULE | UF-100I SYSTEM MODULE | KQO | DATA INNOVATIONS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |