FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 2102957
·
Received May 4, 2011
Report
- Report Number
- 2248721-2011-00061
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 13, 2011
- Report Date
- April 21, 2011
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORPORATION
- Product Code
- JPA
- PMA / PMN Number
- K951072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHOD: MFR/EVAL/INVESTIGATION IN PROCESS. RESULT: COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: NO CONCLUSION CAN BE DRAWN. CUVETTE LOTS BEING RECALLED ((B)(4)) DUE TO HIGHER THAN SPECIFIED BIAS. THE FDA WILL BE NOTIFIED OF FIELD ACTION BY (B)(4) 2011.
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL REPORTS PROTIME MICROCOAGULATION SYSTEM GENERATED "INR HIGH" MESSAGE. INR WITH VENIPUNCTURE WAS 3.42. PT'S THERAPEUTIC RANGE WAS NOT PROVIDED. NO ADVERSE EVENT(S) REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | JPA | INTERNATIONAL TECHNIDYNE CORPORATION | PROTIMERPL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |