FDA Adverse Event
Malfunction
Summary report: N
DIRECT CHECK WHOLE BLOOD CONTROLS
MDR report key: 1396061
·
Received March 31, 2009
Report
- Report Number
- 2250033-2009-00006
- Event Type
- Malfunction
- Date Received
- March 31, 2009
- Date of Event
- March 16, 2009
- Report Date
- March 31, 2009
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GGN
- PMA / PMN Number
- K944691
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MFR EVAL/INVESTIGATION CURRENTLY IN PROCESS.
Description of Event or Problem · 1
CUSTOMER REPORTS RECEIVING A CUT ON (B)(6) 2009 WHILE CRUSHING DIRECT CHECK CONTROL VIAL. CUSTOMER REPORTS NOT USING PROTECTIVE SLEEVE REQUIRED TO ACTIVATE CONTROLS FOR USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIRECT CHECK WHOLE BLOOD CONTROLS | DIRECT CHECK CONTROLS | GGN | INTERNATIONAL TECHNIDYNE CORP. | DCJCPT-N | G8DNC005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |