FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 1711686
·
Received September 10, 2009
Report
- Report Number
- 2248721-2009-00543
- Event Type
- Malfunction
- Date Received
- September 10, 2009
- Date of Event
- December 10, 2008
- Report Date
- August 27, 2009
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP
- Product Code
- GKP
- PMA / PMN Number
- K951072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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. MANUFACTURER METHOD - NO PRODUCT RETURNED FROM USER FACILITY. MFR RESULTS - CUSTOMER COMPLAINT COULD NOT BE CONFIRMED.
Description of Event or Problem · 1
REPORT FOR PT 3 OF 3: 1.4 INR WITH PROTIME SYSTEM ((B)(4)) VS. A 1.7 INR WITH PROTIME SYSTEM ((B)(4)) VS. A 2.5 WITH UNSPECIFIED REFERENCE LABORATORY SYSTEM. PT THERAPEUTIC INR RANGE: 2.0-3.0. 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 | PROTIMEPRO | G8KC283 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |