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 serial#: (b)(4).Additional lot numbers continued from lot#.504037e, id440.
Event or Problem Description
A review of quarterly events indicated that patient samples tested on the echo lumena automated blood bank system produced inaccurate results for known antibodies, an antibody screen assay error; a crossmatch validation error and abo rh mistypes.A review indicated that three (3) patient sample tests [from two (2) patients] using the echo lumena automated blood bank system whereby, the instrument produced discrepant results against known results for aborh typing.The three (3) inaccurate results were for anti-d using anti-d monoclonal series 4 and 5.A review indicated that five (5) patient sample tests using the echo lumena automated blood bank system whereby, the instrument produced false negative results for known antibodies, including: two (2) for the anti-e antibody; one (1) for the anti-fyb antibody; one (1) for the anti-jka antibody and one (1) for the anti-kpa antibody; where the sample was negative on the echo lumena and positive on the neo iris.A review indicated that one (1) patient sample test using the echo lumena automated blood bank system produced an incompatible crossmatch for anti-c.A review indicated that one (1) patient sample test using the echo lumena automated blood bank system where the instrument produced negative screen results using the capture-r ready screen 3 assay; conflicting with the capture-r ready id assay which produced antibody results.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: 16275237
• Report Number: 1034569-2023-00004
• Device Sequence Number: 11997524
• Product Code: KSZ
• UDI-Device Identifier: 10888234002338
• UDI-Public: 10888234002338
• Combination Product (Y/N): N
• PMA/510(K) Number: BK170135
• Number of Events Summarized: 10
• 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): 01/31/2023

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: R394,221161,DP130,E491,R422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2023
• 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