FDA Adverse Event
Other
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 1002877
·
Received February 8, 2008
Report
- Report Number
- 2248721-2008-00006
- Event Type
- Other
- Date Received
- February 8, 2008
- Date of Event
- January 10, 2008
- Report Date
- February 6, 2008
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GKP
- PMA / PMN Number
- K951072
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). MANUFACTURER AWAITING PRODUCT RETURN FROM USER FACILITY.
Description of Event or Problem · 1
CUSTOMER REPORTS NORMAL INR VALUES ATTAINED FOR 3 PATIENTS WITH PROTIME AND SUBSEQUENT HOSPITALIZATION FOR BLEEDING. REPORT IDENTIFIES 4 PROTIME INSTRUMENTS AND MULTIPLE CUVETTE LOTS, BUT CUSTOMER NOT ABLE TO IDENTIFY IF ONE OR ALL ITEMS INVOLVED. REPORT INDICATES CUVETTES STORED UNDER FROZEN CONDITIONS PRIOR TO USE. THIS REPORT IS FOR DEVICE 3 OF 4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | PROTIME INSTRUMENT/5-CHANNEL CUVETTE | GKP | INTERNATIONAL TECHNIDYNE CORP. | PROTIME | H7KWC076 / OTHER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |