FDA Adverse Event
Death
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 1232445
·
Received November 14, 2008
Report
- Report Number
- 2248721-2008-00021
- Event Type
- Death
- Date Received
- November 14, 2008
- Date of Event
- October 15, 2008
- Report Date
- November 14, 2008
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GJS
- PMA / PMN Number
- K010599
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
RESULTS AND CONCLUSIONS: MFR CURRENTLY AWAITING PRODUCT RETURN FROM USER FACILITY.
Description of Event or Problem · 1
REPORT REC'D FROM VISITING NURSE OF PT DIAGNOSED WITH AFIB, ANEMIA, PARTIAL BOWEL OBSTRUCTION, AND END STAGE CARDIAC DISEASE EXPIRING 3 DAYS AFTER PROTIME INR OF 1.5 AND LAB INR OF 2.5. VISITING NURSE BELIEVES NO ASSOCIATION OF INR RESULTS WITH PT'S EXPIRATION, FURTHER NOTES PT HAD A LOW EXPECTATION FOR LONG TERM SURVIVAL DUE TO CHRONIC HEALTH ISSUES, AND THAT RECOMMENDED HOSPICE CARE WAS DECLINED BY FAMILY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | PROTIME INSTRUMENT/3-CHANNEL CUVETTE | GJS | INTERNATIONAL TECHNIDYNE CORP. | L11-01-01RF | G8P3C278 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Death |