FDA Adverse Event
Malfunction
Summary report: N
HEMOCHRON RXDX SYSTEM
MDR report key: 1712023
·
Received September 10, 2009
Report
- Report Number
- 2248721-2009-00509
- Event Type
- Malfunction
- Date Received
- September 10, 2009
- Date of Event
- August 15, 2008
- Report Date
- August 27, 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). 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
THE 36 SECONDS FROM ASSAY IN ONE TEST WELL OF HEMOCHRON RESPONSE SYS VS 585 SECONDS FROM SAME ASSAY IN SECOND TEST WELL. NO REPORT OF ADVERSE EVENT, SERIOUS INJURY, OR INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON RXDX SYSTEM | RESPONSE INST / TUBE | KQG | INTERNATIONAL TECHNIDYNE CORP. | HRS. 110 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |