FDA Adverse Event
Summary report: N
CLINSTAR VERSION 11.1
MDR report key: 10509
·
Received December 13, 1993
Report
- Report Number
- MW1000095
- Date Received
- December 13, 1993
- Report Date
- December 9, 1993
- Manufacturer
- HUFF, BARRINGTON AND OWENS
- Product Code
- LNX
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CO STATES THAT ITS SOFTWARE IS NOT COMPATIBLE WITH ANOTHER CO'S COMPUTER. THE OTHER CO STATES THAT THESE SYSTEMS ARE COMPATIBLE. THE RPTR STATED THAT THE PRODUCTS ARE USED IN A BLOOD BANK AND ANY INCOMPATIBILITY COULD DAMAGE THE DATABASE AND CAUSE A MAJOR PROBLEM. THIS INFO WAS SUBMITTED AS F/U 2/16/94: THIS IS A RESPONSE TO A QUALITY PROBLEM REPORTED BY RPTR ON 12/9/93 CONCERNING REPORTED IMCOMPATIBILITY BETWEEN LAB SYSTEMS. RPTR HAS RECEIVED CONFIRMATION FROM THE OTHER DEVICE MFR THAT NO INCOMPATIBILITY EXISTS. RPTR HAS ALSO RECEIVED CONFIRMATION FROM THIS CO THAT NO INCOMPATIBILITY EXISTS AND RPTR WAS TOLD INCORRECTLY THAT ANY PROBLEM EXISTS. RPTR HAS INSTALLED THE PROGRAMS AND HAS NOT SEEN ANY INCOMPATIBILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLINSTAR VERSION 11.1 | COMPUTER SOFTWARE | LNX | HUFF, BARRINGTON AND OWENS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |