FDA Adverse Event
Malfunction
Summary report: N
HEMOCHRON RESPONSE COAGULATION SYSTEM
MDR report key: 1701345
·
Received May 19, 2010
Report
- Report Number
- 2248721-2010-00083
- Event Type
- Malfunction
- Date Received
- May 19, 2010
- Date of Event
- February 23, 2010
- Report Date
- May 19, 2010
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- KQG
- PMA / PMN Number
- K983475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MFR AWAITING PRODUCT RETURN FOR EVAL.
Description of Event or Problem · 1
HEALTH CARE PROFESSIONAL: REPORTS HEMOCHRON RESPONSE PROBLEM. CUSTOMER CLAIMS HEMOCHRON RESPONSE GIVING ERRONEOUS RESULTS. WELL 1 GIVES HIGH RESULTS AND WHEN SOME SAMPLE IS REPEATED ON ANOTHER INSTRUMENT, EXPECTED RESULT IS DERIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON RESPONSE COAGULATION SYSTEM | HEMOCHRON RESPONSE COAGULATION ANALYZER | KQG | INTERNATIONAL TECHNIDYNE CORP. | HRS.110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |