FDA Adverse Event
Other
Summary report: N
HEMOCHRON ELITE MICROCOAGULATION SYSTEM
MDR report key: 1884170
·
Received October 20, 2010
Report
- Report Number
- 2248721-2010-00151
- Event Type
- Other
- Date Received
- October 20, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 12, 2010
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- JPA
- PMA / PMN Number
- K050016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MANUFACTURER AWAITING ADDITIONAL INFO FOR FURTHER COMPLAINT EVALUATION.
Description of Event or Problem · 1
CUSTOMER REPORTED HEMOCHRON SIGNATURE ELITE INSTRUMENT GAVE A PROTIME RESULT HIGHER THAN A REFERENCE/EXPECTED RESULT. SIGNATURE ELITE PROTIME INR 2.5 (CLINIC) VS. REFERENCE LAB (HOSPITAL) INR 1.7. PT THERAPEUTIC RANGE: 2.5 TO 3.5. THE PT WAS HAVING A TRANSIENT ISCHEMIC DURING A CLINIC VISIT AND WAS ADMITTED TO HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON ELITE MICROCOAGULATION SYSTEM | SIGNATURE ELITE INSTRUMENT | JPA | INTERNATIONAL TECHNIDYNE CORP. | ELITE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |