FDA Adverse Event
Other
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 965657
·
Received December 14, 2007
Report
- Report Number
- 2248721-2007-00015
- Event Type
- Other
- Date Received
- December 14, 2007
- Date of Event
- November 1, 2007
- Report Date
- December 14, 2007
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GJS
- PMA / PMN Number
- K010599
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER METHOD, RESULTS AND CONCLUSIONS: MANUFACTURER AWAITING PRODUCT RETURN.
Description of Event or Problem · 1
PER PHYSICIAN DOSING DIRECTIVE, GUARDIAN INCREASED PATIENT COUMADIN DOSE BASED ON PROTIME READING. GUARDIAN REPORTS, PATIENT LATER BEGAN VOMITING AND TOOK TO ER. PATIENT IS HYDROCEPHALIC WITH IMPLANTED SHUNT AND MECHANICAL HEART VALVE AND SUBSEQUENTLY ADMITTED FOR INVASIVE DIAGNOSTIC PROCEDURE RELATED TO HYDROCEPHALIC SHUNT. LAB INR PERFORMED IN SUPPORT OF DIAGNOSTIC PROCEDURE INDICATED INR TOO HIGH AND PHYSICIAN ELECTED TO DELAY PROCEDURE. COUMADIN LEVEL SUBSEQUENTLY LOWERED AND PROCEDURE COMPLETED WITHOUT PATIENT COMPLICATIONS OR INJURY. PATIENT DISCHARGED AND GUARDIAN CONTINUED USE OF PROTIME WITHOUT SUBSEQUENTLY REPORTS OF DISCREPANCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | PROTIME INSTRUMENT / 3-CHANNEL CUVETTE | GJS | INTERNATIONAL TECHNIDYNE CORP. | PROTIME | J7P3C344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Other |