FDA Adverse Event
Malfunction
Summary report: N
GALILEO
MDR report key: 1880102
·
Received October 22, 2010
Report
- Report Number
- 1034569-2010-00221
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 24, 2010
- Report Date
- October 22, 2010
- Manufacturer
- IMMUCOR
- Product Code
- KSZ
- PMA / PMN Number
- BK040013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THE BLUD_DIRECT IMAGES WERE OBTAINED FROM THE INSTRUMENT AND REVIEWED BY IMMUCOR. ALL REACTIONS WERE NEGATIVE EXCEPT FOR THE POSITIVE CONTROL (4+). A FIELD SERVICE ENGINEER PERFORMED A CHECKLIST OF VERIFICATIONS AND DAILY MAINTENANCE ACTIVITIES ON THE CUSTOMER'S INSTRUMENT. NO PROBLEMS WERE IDENTIFIED. PATIENT SAMPLE WAS NO LONGER AVAILABLE FOR TESTING. THREE DIFFERENT SAMPLES WERE TESTED AND THE EXPECTED RESULTS WERE OBTAINED.
Description of Event or Problem · 1
CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS ON THE GALILEO INSTRUMENT WITH A SAMPLE THAT WAS PREVIOUSLY TESTED AT A DIFFERENT FACILITY ON AN ECHO INSTRUMENT WHERE POSITIVE RESULTS WERE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GALILEO | AUTOMATED BLOOD BLANK ANALYZER | KSZ | IMMUCOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |