FDA Adverse Event
Malfunction
Summary report: N
HEMOCHRON RESPONSE SYSTEM
MDR report key: 1711732
·
Received September 10, 2009
Report
- Report Number
- 2248721-2009-00425
- Event Type
- Malfunction
- Date Received
- September 10, 2009
- Date of Event
- October 11, 2007
- Report Date
- August 25, 2009
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- KQG
- PMA / PMN Number
- K983475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CUSTOMER EVALUATION REPORTED: ESV CONDUCTED WITH ACCEPTABLE RESULTS. LIQUID EQC CONDUCTED WITH ACCEPTABLE RESULTS. MFR EVAL / INVESTIGATION PENDING ADD'L INFO FROM CONSUMER. MFR METHOD, RESULTS, CONCLUSIONS: MFR EVAL / INVESTIGATION PENDING ADD'L INFO FROM CONSUMER.
Description of Event or Problem · 1
HEMOCHRON RESPONSE TEST WELL #1 AT 700 SECONDS WHILE TEST WELL #2 AT 500 SECONDS. PROCEDURE, THERAPEUTIC RANGE FOR PROCEDURE, AND BASELINE NOT REPORTED. NO REPORT OF ADVERSE EVENT, SERIOUS INJURY, OR INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON RESPONSE SYSTEM | RESPONSE INST / TUBE | KQG | INTERNATIONAL TECHNIDYNE CORP. | RESPONSE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |