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

Model Number	0086998
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional serial numbers continued : m0154,m20912,m20863.Additional lot numbers continued : m028.
Event or Problem Description
A review of events indicated that patient samples tested on the echo lumena automated blood bank system produced inaccurate results.A review indicated that seven patient sample tests using the echo lumena automated blood bank system produced nine unexpected false negative results; two for the anti-e antibody; two for the anti-jka antibody; one for the anti-fya antibody; one for the anti-k antibody; one for the anti-k antibody, one for the anti-m antibody and one for the anti-kpa antibody.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.Two additional instrument malfunctions generated inaccurate rh typing results based on historical results; which had typed o positive.Our investigation revealed that the two patients had very recent transfusions of negative blood.Subsequent testing of reagent retention lots for anti-d series 4 and 5 produced expected results.

• Brand Name: ECHO LUMENA
• 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: 14257576
• Report Number: 1034569-2022-00009
• Device Sequence Number: 14692797
• Product Code: KSZ
• UDI-Device Identifier: 10888234002338
• UDI-Public: 10888234002338
• Combination Product (Y/N): N
• PMA/510(K) Number: BK170135
• Number of Events Summarized: 9
• 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: 0086998
• Device Catalogue Number: 0086998
• Device Lot Number: R281,ID426,R318,NU653,505891
• 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