FDA Adverse Event
Malfunction
Summary report: N
SAFETRACE TX
MDR report key: 356291
·
Received October 11, 2001
Report
- Report Number
- 2951268-2001-00002
- Event Type
- Malfunction
- Date Received
- October 11, 2001
- Report Date
- October 11, 2001
- Manufacturer
- GLOBAL MED TECHNOLOGIES, INC./WYNDGATE TECHNOLOGIES DIV
- Product Code
- MMH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PROHIBITING FACTORS MAY BE POSTED OR CLEARED INCORRECTLY FROM THE RESULT ENTRY WINDOW IN THE SCENARIO OF HAVING A PRODUCT SELECTED FOR ONE PT AND PERFORMING AN ANTIGEN TYPING TEST FOR THE SAME PRODUCT ON A SECOND PT'S ORDER. IF A PRODUCT IS SELECTED TO BE ISSUED TO ONE PT (PT 1), AND THEN TESTING IS PERFORMED FOR ANOTHER PT'S ORDER (PT 2) WITH THE SAME PRODUCT, THE COMPATIBILITY CHECKS ARE PERFORMED FOR PT 2, AND THE RESULTS ARE POSTED TO PT 1. THIS CAN CAUSE THE PRODUCT TO BE ISSUED WITH TOO MANY FACTORS OR WITH NO OR INCORRECT PROHIBITING FACTORS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45853 | SAFETRACE TX | TRANSFUSION SERVICE MANAGEMENT INFORMATION SYST. | MMH | GLOBAL MED TECHNOLOGIES, INC./WYNDGATE TECHNOLOGIES DIV | 1.X-2.1 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |