FDA Adverse Event
Malfunction
Summary report: N
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/A
MDR report key: 2272147
·
Received September 14, 2011
Report
- Report Number
- 2250033-2011-00024
- Event Type
- Malfunction
- Date Received
- September 14, 2011
- Date of Event
- August 18, 2011
- Report Date
- August 18, 2011
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GGN
- PMA / PMN Number
- K882481
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHOD: NO PRODUCT RETURNED. RESULT: RECORD EVALUATION COMPLETED. PRODUCT MET ALL RELEASE CRITERIA. CONCLUSION: USER ERROR MAY HAVE CONTRIBUTED TO ALLEGED EVENT. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL REPORTS END USER SUSTAINED AN INJURY WHILE USING HEMOCHRON CONTROL ACT TEST TUBE. THE NURSE WAS RUNNING LQC FOR THE HEMOCHRON RESPONSE WHEN SHE SUSTAINED A NEEDLESTICK INJURY. NO REPORT OF SERIOUS INJURY, OR ADMINISTRATION OF MEDICAL TREATMENT. MEDICAL SAFETY DATA SHEET PROVIDED TO CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON CONTROL ACT TEST TUBE NORMAL/A | GGN | INTERNATIONAL TECHNIDYNE CORP. | QCACT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |