FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 1486864
·
Received August 13, 2009
Report
- Report Number
- 2248721-2009-00258
- Event Type
- Malfunction
- Date Received
- August 13, 2009
- Date of Event
- January 5, 2009
- Report Date
- August 10, 2009
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GKP
- PMA / PMN Number
- K961835
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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 EVALUATION PROCEDURES. MANUFACTURER METHOD- NO PRODUCT RETURNED FROM USER FACILITY. MANUFACTURER RESULTS - CUSTOMER COMPLAINT COULD NOT BE CONFIRMED.
Description of Event or Problem · 1
THE 2.6 INR WITH PROTIME SYSTEM VS. 3.6 INR WITH UNSPECIFIED LAB SYSTEM. PATIENT THERAPEUTIC INR RANGE: 2.5 - 3.5. 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. | PROTIMEPST | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |