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

Model Number	0064599
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A review of the events indicated that three (3) patient samples tested on the galileo neo, automated blood bank system produced inaccurate aborh results.In two (2) tests, the instrument incorrectly produced a negative result for anti-a.In a third test, the instrument's pipettor did not allow for a test result that was accurate.With one mistype, its is likely the malfunction was caused by a customer's error; however our analysis of customer error could not be fully verified.With the second mistype; an instrument pipettor error rendered the instrument as intermittently inoperable.For the third mistype, the result on the galileo neo instrument typed ab+ against b+ in tube.The product investigation lab performed aborh tests on five (5) known aborh typed in house donor samples on the galileo neo using retention anti-a ser1 lot 101055e.Controls performed as expected and all in house samples resulted as expected.Retention product performed as expected.In each circumstance, subsequent testing of relevant reagent retention lots produced accurate results.Additional investigations related to quality control processes; test procedures and other facts could not determine any direct cause of the missed antibody screening and the malfunctions are allocated against the analytical instrument.

• Brand Name: GALILEO NEO
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM, PRODUCT CODE:KSZ
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway dr; norcross GA 30091 5625
• Manufacturer Contact: mr. yorek ; 3130 gateway dr.; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 16275236
• Report Number: 1034569-2023-00001
• Device Sequence Number: 4758036
• Product Code: KSZ
• UDI-Device Identifier: 10888234001041
• UDI-Public: 10888234001041
• Combination Product (Y/N): N
• PMA/510(K) Number: BK210562
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2023

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: Health Professional
• Device Model Number: 0064599
• Device Catalogue Number: 0064599
• Device Lot Number: 101055E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown