FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 2193242
·
Received July 13, 2011
Report
- Report Number
- 2248721-2011-00084
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- May 23, 2011
- Report Date
- June 14, 2011
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GKP
- PMA / PMN Number
- K951072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4): DEVICE HISTORY RECORD REVIEWED FOR NCMR. NO PRODUCT RETURNED. RECORD EVAL COMPLETED. PRODUCT MET ALL RELEASE CRITERIA. DEVICE NOT RETURNED. NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
A HEALTHCARE PROFESSIONAL REPORTS READING WITH PROTIME MICROCOAGULATION SYSTEM DIFFERED FROM VENOUS DRAW. PROTIME GENERATED INR 2.3. THE FOLLOWING DAY, PT TESTED IN PHYSICIAN'S OFFICE ON DIFFERENT POINT OF CARE INSTRUMENT AND GENERATED INR 4.8. THE PT'S THERAPEUTIC RANGE 2.5 TO 3.5. NO ADVERSE EVENT(S) REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | GKP | INTERNATIONAL TECHNIDYNE CORP. | PROTIMEPST |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |