FDA Adverse Event
Malfunction
Summary report: N
GALILEO
MDR report key: 726743
·
Received June 15, 2006
Report
- Report Number
- 1034569-2006-00038
- Event Type
- Malfunction
- Date Received
- June 15, 2006
- Date of Event
- May 17, 2006
- Report Date
- June 14, 2006
- Manufacturer
- IMMUCOR
- Product Code
- KSZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT WAS SERVICED. THE PIPETTE RINSE SUPPLY LINE WAS NOT POSITIONED CORRECTLY IN THE SYSTEM LIQUID CONTAINER. IT WAS REPOSITIONED TO THE APPROPRIATE POSITION. THE REPAIR BROUGHT THE INSTRUMENT BACK WITHIN OPERATING SPECIFICATIONS. THE RETURNED CUSTOMER SAMPLES CORRECTLY TYPED AS O, RH POSITIVE AND A, RH NEGATIVE, RESPECTIVELY, WHEN TESTED ON AN IN-HOUSE GALILEO. THE GALILEO OPERATOR MANUAL PROVIDES GUIDANCE AND WARINGS REGARDING THE COMPARISON OF ABO-RH RESULTS TO PATIENT AND DONOR HISTORY PRIOR TO RELEASE OF BLOOD PRODUCTS FOR TRANSFUSION. (510(K)#BK040013)
Description of Event or Problem · 1
RH DISCREPANCIES ON THE GALILEO INSTRUMENT WERE REPORTED FOR 2 PATIENT SAMPLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GALILEO | KSZ | KSZ | IMMUCOR | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |