FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 1711829
·
Received September 10, 2009
Report
- Report Number
- 2248721-2009-00435
- Event Type
- Malfunction
- Date Received
- September 10, 2009
- Date of Event
- October 31, 2007
- Report Date
- September 2, 2009
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GKP
- PMA / PMN Number
- K951072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
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.
Description of Event or Problem · 1
REPORT FOR PT 2 OF 3: A 1.9 INR WITH PROTIME SYSTEM, LOT NUMBER H7K3C288 VS. 1.3 INR WITH PROTIME SYSTEM, LOT NUMBER H7KWC078A. PT THERAPEUTIC INR RANGE NOT REPORTED. NO REPORT OF ADVERSE EVENT, SERIOUS INJURY, OR INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | PROTIME INSTRUMENT | GKP | INTERNATIONAL TECHNIDYNE CORP. | L11-01-01 | H7K3C288 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |