FDA Adverse Event
Malfunction
Summary report: N
HEMOCHRON RESPONSE COAGULATION SYSTEM
MDR report key: 2093420
·
Received April 12, 2011
Report
- Report Number
- 2248721-2011-00047
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Report Date
- March 15, 2011
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- JPA
- PMA / PMN Number
- K983475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS MDR SUBMITTED (B)(4) 2011 (B)(4) (CUVETTE LOTS J9FTE225A AND H9FTE197B). METHOD: DEVICE HISTORY RECORD REVIEWED FOR (B)(4) AND CAPA. RESULT: RECORD EVAL COMPLETED. COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.
Description of Event or Problem · 1
IN-COUNTRY REP FORWARDED A REPORT OF NO CLOT DETECTED ON HEMOCHRON RESPONSE INSTRUMENT. THE CUSTOMER OBSERVED NO CLOT DETECTED ERRORS ON HEMOCHRON RESPONSE COAGULATION SYSTEM. THIS EVENT OCCURRED OUTSIDE THE U.S. NO ADVERSE EVENT(S) REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON RESPONSE COAGULATION SYSTEM | JPA | INTERNATIONAL TECHNIDYNE CORP. | HRS.110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |