FDA Adverse Event
Other
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 2195328
·
Received June 30, 2011
Report
- Report Number
- 2248721-2011-00077
- Event Type
- Other
- Date Received
- June 30, 2011
- Report Date
- June 6, 2011
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GJS
- PMA / PMN Number
- K961835
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (CUVETTE LOT# D1P3C168). METHOD: DEVICE HISTORY RECORD REVIEWED FOR NCMR AND CAPA. NO PRODUCT RETURNED. RESULT: RECORD EVALUATION COMPLETED. PRODUCT MET ALL RELEASE CRITERIA. CONCLUSION: DEVICE NOT RETURNED. NO CONCLUSION CAN BE DRAWN. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.
Description of Event or Problem · 1
PATIENT SELF TESTER WITH PROTIME MICROCOAGULATION SYSTEM REPORTS IN LAB SHE GETS INR 5.0 AND ON PROTIME SHE GETS INR 3.7. SELF TESTER CALLED DOCTOR WHEN SHE "NOTICED HEMATOMAS ON HER LEGS". DOCTOR SENT HER TO LAB AND INR WAS 5.0. SHE TESTED TWO HOURS LATER AT HOME AND GOT INR 3.7. THE PATIENT'S THERAPEUTIC RANGE PT/INR 3.0-4.0.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | GJS | INTERNATIONAL TECHNIDYNE CORP. | PROTIMEPST |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |