FDA Adverse Event
Malfunction
Summary report: N
GALILEO
MDR report key: 1935723
·
Received December 22, 2010
Report
- Report Number
- 1034569-2010-00260
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- November 24, 2010
- Report Date
- December 22, 2010
- Manufacturer
- IMMUCOR
- Product Code
- KSZ
- PMA / PMN Number
- BK040013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF REACTIONS STRENGTHS CELL 1 - HAD A NEGATIVE RESULT WITH A REACTION STRENGTH OF 11 AND CELL 2 HAD A NEGATIVE RESULT WITH A REACTION STRENGTH OF 18. BASED ON REVIEW OF SAMPLE DATA THIS ISSUE APPEARS TO BE SAMPLE RELATED.
Description of Event or Problem · 1
CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN TESTING A SAMPLE WITH A KNOWN ANTI-E ON A 2 CELL SCREENING ASSAY ON THE GALILEO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GALILEO | BLOOD BANK ANALYZER | KSZ | IMMUCOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR |