FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 1712024
·
Received September 10, 2009
Report
- Report Number
- 2248721-2009-00500
- Event Type
- Malfunction
- Date Received
- September 10, 2009
- Date of Event
- June 30, 2008
- Report Date
- August 27, 2009
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GKP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS MDR IS SUBMITTED BASED UPON A RETROSPECTIVE REVIEW OF COMPLAINT REPORTS FROM 2007-2008 IN LIGHT OF REVISED ITC MDR EVAL PROCEDURES. MFR METHOD: NO PRODUCT RETURNED FROM USER FACILITY. MFR RESULTS: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. MFR CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
USER REPORTS SIGNIFICANTLY DIFFERENT INRS WITH PROTIME SYSTEM DURING USE. SPECIFIC RESULTS AND TIMES NOT REPORTED. PT THERAPEUTIC INR RANGE NOT REPORTED. NO REPORT OF ADVERSE EVENT, SERIOUS INJURY, OR INTERVENTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | PROTIME INSTRUMENT | GKP | INTERNATIONAL TECHNIDYNE CORP. | PROPH220 | C8KWC028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | IN (B)(4) TRIAL |