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
Additional Manufacturer Narrative
Additional serial numbers continued.Additional lot numbers continued.
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-d.In a third test; an a positive cord blood sample mistyped as ab positive.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: 15705133
• Report Number: 1034569-2022-00015
• Device Sequence Number: 6584410
• 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): 10/31/2022

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: ID433, 203896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2022
• 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