FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 1494103
·
Received August 18, 2009
Report
- Report Number
- 2248721-2009-00213
- Event Type
- Malfunction
- Date Received
- August 18, 2009
- Date of Event
- June 2, 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 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. MANUFACTURER CONCLUSIONS - NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
ORIGINALLY REPORTED FROM IDTF 3.7 INR WITH PROTIME SYSTEM VS. 2.7 INR WITH UNSPECIFIED LAB SYSTEM. PATIENT THERAPEUTIC 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 | PROTIMEPST | B8P3C077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |