FDA Adverse Event
Other
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 2094121
·
Received May 11, 2011
Report
- Report Number
- 2248721-2011-00067
- Event Type
- Other
- Date Received
- May 11, 2011
- Date of Event
- March 1, 2011
- Report Date
- April 22, 2011
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GJS
- PMA / PMN Number
- K961835
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) (CUVETTE LOT #L0P3C526). METHOD: DEVICE HAS BEEN REQUESTED. NO PRODUCT RETURNED. RESULT: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
PATIENT SELF TESTER WITH PROTIME MICROCOAGULATION SYSTEM REPORTS HOSPITALIZATION IN (B)(6) 2011 ''FOR CLOTS ON VALVES." ON (B)(6) 2011, PT/INR RESULTS 3.3 AND LAB GENERATED PT/INR 4.5. THE PATIENT'S THERAPEUTIC RANGE IS PT/INR 3.0-3.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | GJS | INTERNATIONAL TECHNIDYNE CORP. | L11-01-01C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Hospitalization |