FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 2171447
·
Received June 30, 2011
Report
- Report Number
- 2248721-2011-00078
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 4, 2011
- Report Date
- June 6, 2011
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GJS
- PMA / PMN Number
- K961835
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHODS: DEVICE HISTORY RECORD REVIEWED FOR NCMR AND CAPA. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS: RECORD EVALUATION COMPLETED. COMPLAINT COULD NOT BE CONFIRMED. DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. DEVICE OPERATED ACCORDING TO SPECIFICATIONS. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.
Description of Event or Problem · 1
PATIENT SELF TESTER WITH PROTIME MICROCOAGULATION SYSTEM REPORTS DISCREPANT RESULTS. THE CLINIC INR 2.3 AND ON PROTIME RESULT INR 1.5. THE PATIENT'S THERAPEUTIC RANGE PT/INR 2.0-3.0. NO ADVERSE EVENT(S) REPORTED.
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 |