FDA Adverse Event
Malfunction
Summary report: N
GALILEO
MDR report key: 1240023
·
Received November 24, 2008
Report
- Report Number
- 1034569-2008-00573
- Event Type
- Malfunction
- Date Received
- November 24, 2008
- Date of Event
- October 31, 2008
- Report Date
- November 21, 2008
- Manufacturer
- IMMUCOR, INC.
- Product Code
- KSZ
- PMA / PMN Number
- BK040013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
AN AUTOMATIC CAMERA ADJUSTMENT WAS DONE. ASKED CUSTOMER TO REPEAT THE SAMPLE; CUSTOMER RERAN THE SAMPLE AND STILL GOT A NEGATIVE RESULT. A SERVICE CALL WAS MADE. THE CAMERA MODULE WAS REPLACED. RAN QC_ASSAY, 2_CELL, SCREEN AND ABORH WITH ONE PATIENT SAMPLE WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS RETURNED TO CUSTOMER USE.
Description of Event or Problem · 1
CUSTOMER REPORTED A NEGATIVE ANTIBODY SCREEN ON A PATIENT SAMPLE CONTAINING ANTI-E WHEN TESTED ON GALILEO. THE CUSTOMER REPORTED VISUALLY THAT THE REACTIONS LOOKED REACTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GALILEO | AUTOMATED BLOOD BANK ANALYZER | KSZ | IMMUCOR, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |