FDA Adverse Event
Malfunction
Summary report: N
DIRECT CHECK QUALITY CONTROL
MDR report key: 1661687
·
Received April 14, 2010
Report
- Report Number
- 2250033-2010-00007
- Event Type
- Malfunction
- Date Received
- April 14, 2010
- Date of Event
- March 23, 2010
- Report Date
- April 15, 2010
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GGN
- PMA / PMN Number
- K944691
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHOD - NO PRODUCT RETURNED FROM USER FACILITY. RESULTS - CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSIONS - NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
CUSTOMER REPORTS BEING CUT BY THE DIRECTCHECK CONTROL AMPULE WHILE CRUSHING IT. CUSTOMER WAS USING THE PROTECTIVE SLEEVE TO ACTIVATE THE CONTROL. HOWEVER, THE PLASTIC SHIELD WAS REMOVED TO SQUEEZE THE CONTROL DROPS ON TO THE CUVETTE. A PIECE OF CRUSHED GLASS PIERCED THE CONTROL'S OUTER PLASTIC TUBE AND CUT THE CUSTOMER'S FINGER. NO REPORT OF SERIOUS INJURY, OR INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIRECT CHECK QUALITY CONTROL | DIRECT CHECK NORMAL ACT-LR | GGN | INTERNATIONAL TECHNIDYNE CORP. | DCJLR-A | J9DCA021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |