FDA Adverse Event
Other
Summary report: N
HEMOCHRON SIGNATURE ELITE WHOLE BLOOD MICROCO
MDR report key: 921745
·
Received September 27, 2007
Report
- Report Number
- 2248721-2007-00004
- Event Type
- Other
- Date Received
- September 27, 2007
- Date of Event
- July 13, 2007
- Report Date
- August 29, 2007
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP. (ITC)
- Product Code
- JPA
- PMA / PMN Number
- K050016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INFORMATION FOR CASE CURRENTLY UNDER REVIEW AND INVESTIGATION BY MANUFACTURER. DEVICE HAS BEEN RETURNED TO ITC FROM USER FACILITY FOR EVALUATION, BUT AT TIME OF THE MDR FILING, EVALUATION IS IN PROCESS.
Description of Event or Problem · 1
A PT UNDERGOING A SCHEDULED CARDIO CATH INTERVENTION REQUIRED COR DURING THE PROCEDURE IN WHICH HEMOCHRON SIGNATURE ELITE WIT ACT-LR WAS UTILIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON SIGNATURE ELITE WHOLE BLOOD MICROCO | HEMOCHRON SIGNATURE ELITE/ACT-LR ASSAY | JPA | INTERNATIONAL TECHNIDYNE CORP. (ITC) | JACT-LR (ASSAY) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA YR | Other |