FDA Adverse Event
Malfunction
Summary report: N
GALILEO ECHO
MDR report key: 1904897
·
Received November 22, 2010
Report
- Report Number
- 1034569-2010-00249
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Date of Event
- October 20, 2010
- Report Date
- November 19, 2010
- Manufacturer
- IMMUCOR
- Product Code
- KSZ
- PMA / PMN Number
- BK070016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
UPON REVIEW OF THE RESULT FILES FOR THE NEGATIVE REACTIONS, THE E POSITIVE CELLS VISUALLY APPEARED POSITIVE. CUSTOMERS WERE ADVISED TO VISUALLY INSPECT ALL NEGATIVE ANTIBODY SCREEN AND ID RESULTS ON THE ECHO. THIS ISSUE WAS COMMUNICATED TO CUSTOMERS IN TECHNICAL COMMUNICATION (B)(4) ON NOVEMBER 25, 2009.
Description of Event or Problem · 1
CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN AND CAPTURE-R READY-ID ASSAYS ON THE ECHO INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GALILEO ECHO | BLOOD BANK ANALYZER | KSZ | IMMUCOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |