FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 1494106
·
Received August 18, 2009
Report
- Report Number
- 2248721-2009-00216
- Event Type
- Malfunction
- Date Received
- August 18, 2009
- Date of Event
- August 12, 2008
- Report Date
- August 4, 2009
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GKP
- PMA / PMN Number
- K951072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- 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 EVALUATION PROCEDURES.
Description of Event or Problem · 1
2.2 INR WITH PROTIME SYSTEM VS 3.56 INR WITH UNSPECIFIED LAB SYSTEM. PATIENT INR THERAPEUTIC RANGE: 2.0 - 3.0. 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. | PROTIMEPRO | A8K3C023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |