FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 1711986
·
Received September 10, 2009
Report
- Report Number
- 2248721-2009-00473
- Event Type
- Malfunction
- Date Received
- September 10, 2009
- Date of Event
- December 19, 2007
- Report Date
- August 18, 2009
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GKP
- PMA / PMN Number
- K951072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 EVAL PROCEDURES. MANUFACTURER METHOD: NO PRODUCT RETURNED FROM USER FACILITY. MANUFACTURER RESULTS: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED.
Description of Event or Problem · 1
REPORT FOR PT 3 OF 4: A 2.3 INR WITH PROTIME SYSTEM VS 1.6 INR WITH SAME PROTIME DEVICE 2 WEEKS LATER. NO REPEAT TESTING OR OTHER RESULT CONFIRMATION REPORTED. 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 | G7KWC071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |