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

Model Number	0086998
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 from: (b)(4).Additional lot numbers continued from: r390, nu804, 504037e, e491 , 203901, 221098, dn138.
Event or Problem Description
A review of events indicated that patient samples tested on the echo lumena automated blood bank system produced inaccurate results for antibodies.A review indicated that sixteen (16) patient sample tests (over thirteen events) using the echo lumena automated blood bank system produced nine (9) inaccurate results for abo and rh testing.Of the nine (9) inaccurate results; seven (7) were related to anti-d and two (2) were related to anti-b in addition, the instrument had unexpected false negative results for antibodies; including: four (4) for the anti-e antibody; two (2) for the anti-fya antibody and one (1) for the anti-k 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.

• 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: mr. yorek ; 3130 gateway dr.; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 15705129
• Report Number: 1034569-2022-00018
• Device Sequence Number: 6584408
• Product Code: KSZ
• UDI-Device Identifier: 10888234002338
• UDI-Public: 10888234002338
• Combination Product (Y/N): N
• PMA/510(K) Number: BK170135
• Number of Events Summarized: 16
• 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: 0086998
• Device Catalogue Number: 0086998
• Device Lot Number: 504033E,221080,504035E,505896
• 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