MAUDE Adverse Event Report: IMMUCOR, INC. GALILEO NEO; AUTOMATED BLOOD BANK SYSTEM

Model Number 0064599

Device Problems False Negative Result (1225); False Positive Result (1227); Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This report summarizes 3 malfunction events.A review of the events indicated that three (3) patient samples tested on the galileo neo automated blood bank system produced a different abo/rh phenotype result and two false negative results for antibodies versus previous or expected results, utilizing forward abo assays and the capture-r ready id assay.One patient sample on the galileo neo produced a false negative for anti-k antibody.One patient test produced a false negative for the anti-jka antibody.A third patient's test experienced an instrument malfunction that led to an abo mistype.Through post event tests and investigations, no specific causes were determined for the malfunctions.

• Brand Name: GALILEO NEO
• Type of Device: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross, ga
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross, ga
• Manufacturer Contact: howard yorek ; 3130 gateway drive; norcross, ga ; 4412051473
• MDR Report Key: 10345963
• MDR Text Key: 203853333
• Report Number: 1034569-2020-00042
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234001041
• UDI-Public: 10888234001041
• Combination Product (y/n): N
• PMA/PMN Number: BK100033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0064599
• Device Catalogue Number: 64599
• Device Lot Number: 5030090928,5030090716,630050
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1