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 unexpected abo/rh or abo crossmatch phenotype results versus prior test results or, subsequent manual tube/gel test results.One (1) patient's crossmatch test on the galileo neo resulted as compatible and should have been incompatible, given the patient's sample was anti-c and the donor sample was c+.One (1) test produced an abo/rh forward testing mistype result due to a false positive result of b positive; whereby historical results determined a phenotype of ab positive.One (1) galileo neo result was incorrect with a b+ result instead of an ab+ result.The galileo neo resulted the donor as b positive.The donor blood was retested in a reference lab and resulted as ab positive.The donor blood was not used and returned after testing by the reference lab.Tube interpretation resulted as asubb positive, with an anti-a result of 1+.Galileo neo's operation manual provides limitations whereby, the neo cannot reliably detect hemagglutination reactions graded as 1+ or less in test tube methodology.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: 10016362
• MDR Text Key: 209442186
• Report Number: 1034569-2020-00025
• 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: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• 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: UA16044583,203820,SC649
• 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