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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. GALILEO NEO; AUTOMATED BLOOD BANK SYSTEM
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IMMUCOR, INC. GALILEO NEO; AUTOMATED BLOOD BANK SYSTEM Back to Search Results
Catalog Number 0064599
Medical Device Problem Code False Negative Result (1225)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/15/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method to assess the testing instrument in question on (b)(6) 2019.An immucor field service engineer (fse) visited the customer site to assess the testing instrument in question on (b)(6) 2019, and determined that the reagent probe had build-up inside the tube and that the reagent probe required to be replaced, which was done.The internal immucor record number for this report is (b)(4).
 
Event or Problem Description
On (b)(6) 2019, a customer site reported some abo and rh (d) mistypes when tested on a galileo neo instrument, as part of a single plate testing event.
 
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Brand Name
GALILEO NEO
Common Device Name
AUTOMATED BLOOD BANK SYSTEM
Manufacturer (Section D)
IMMUCOR, INC.
3130 gateway drive
norcross GA 30091 5625
MDR Report Key8408341
Report Number1034569-2019-00050
Device Sequence Number2326220
Product Code KSZ
UDI-Device Identifier10888234001041
UDI-Public10888234001041
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
BK100033
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number0064599
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/15/2019
Initial Report FDA Received Date03/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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