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

Model Number	0064597
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227)
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 patient samples tested on the neo iris, automated blood bank system produced inaccurate results.A review indicated that patient sample tests using the neo iris automated blood bank system produced three false negative results for the anti-k antibody; one false negative result for the anti-c antibody and one false negative for the anti-s antibody.Additionally, one patient sample produced a false positive test result for the anti-k antibody.Two instrument malfunctions produced inaccurate abo results using the abo forward typing assay based on a historical result for the patient.Inaccurately typing anti-d and anti-b.Our investigation determined that the anti-d inaccurate result was partially caused by operator erro; given the fact that no anti-d reagent was pipetted during the sample test run.In all cases, subsequent testing of reagent retention lots, reviews of design history records and reagent antigen validation testing of the initial bulk product used for commercial vialing showed acceptable results.No single reason for the false negatives, false positive and inaccurate abo or rh results was determined and the malfunctions were allocated against the analytical instrument.
Additional Manufacturer Narrative
Additional serial number from: none.

• Brand Name: NEO IRIS
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM, PRODUCT CODE:KSZ
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway dr; norcross GA 30091 5625
• Manufacturer Contact: howard yorek ; 3130 gateway dr.; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 14257533
• Report Number: 1034569-2022-00007
• Device Sequence Number: 4961276
• Product Code: KSZ
• UDI-Device Identifier: 10888234002321
• UDI-Public: 10888234002321
• Combination Product (Y/N): N
• PMA/510(K) Number: BK210560
• Number of Events Summarized: 5
• 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): 04/29/2022

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: 0064597
• Device Catalogue Number: 0064597
• Device Lot Number: E459,504021,924680,624019
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown