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

Model Number	0064597
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 lot numbers: 203901.
Event or Problem Description
A review of the events indicated that four (4) patient samples tested on the neo iris, automated blood bank system produced inaccurate abo results.Inaccurate result # 1: customer reports unexpected positive reaction on neo iris serial # (b)(4).The one (1) sample produced a 4+ result for anti-a.The same sample tested in tube as negative for anti-a.The sample was tested again on the neo iris and produced a negative result for anti-a.Customer stated there were 4 patient samples in the run and only one sample had an issue.Inaccurate result # 2: customer stated they had an issue with a neo instrument producing a patient typing as o positive.Customer stated as a new patient, their policy requires a second sample be tested.Customer stated the second sample was tested on an echo and gave an a positive result.Customer stated they repeated the initial sample in tube, on the neo and echo and received a result of a positive.Customer states the sample was run again with same batch that it was initially tested and received a result of a positive.Inaccurate result # 3: neo iris serial # (b)(4) customer reported an abo discrepancy customer reported outside contract states pt history of o positive on many occasions customer reported patient as a positive customer tested manually and repeat on instrument result of o positive for both customer inquiring if instrument will flag when id manually scanned or entered customer reports all qc and maintenance up to date at time of affected run all other samples run around the same time resulted as expected inaccurate result # 4: customer reports an abo mistype on neo iris serial # (b)(4).Customer states they were performing confirming units on 100371.Customer states they received ab pos results on units w286822048335 and w286822086955 customer states they repeated the samples on neo 100498 and received a positive results for both units.Customer states they also repeated the units on 100371 and received a positive results.The investigation pointed to customer sample error but it could not be replicated.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: 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: mr. yorek ; 3130 gateway dr.; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 15705264
• Report Number: 1034569-2022-00016
• Device Sequence Number: 17376524
• Product Code: KSZ
• UDI-Device Identifier: 10888234002321
• UDI-Public: 10888234002321
• Combination Product (Y/N): N
• PMA/510(K) Number: BK210560
• Number of Events Summarized: 4
• 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: 0064597
• Device Catalogue Number: 0064597
• Device Lot Number: 101050E 5030100498,5030100429
• 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