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

Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A review of quarterly events indicated that for nine (9) patient/donor samples tested using the echo lumena automated blood bank system, a malfunction occurred resulting in the instrument producing incorrect results.A review indicated that six (6) patient samples and three (3) donor samples tested using the echo lumena automated blood bank system produced inaccurate results: a missed anti-c and anti-e for one (1) patient sample during an antibody screen; a missed anti-e for one (1) patient sample during an antibody id; a missed anti-fya for one (1) patient sample during an antibody screen; a missed anti-fya for one (1) patient sample during an antibody id; a missed anti-jsa for one (1) patient sample during an antibody id; a missed anti-fya and anti-kell for one (1) patient sample during an antibody screen; and unexpected abo typing results for three (3) donor samples.
Additional Manufacturer Narrative
No common specific root cause or defect was identified.The conclusion(s) code(s) reported herein are assigned according to the facts presented by the affected customer and immucor's assessment and investigation of those facts.When possible, immucor attempts to obtain the actual samples and reagents involved; retention reagents of the same lot that was involved in the event may be used during the investigation if indicated.Also, when possible, immucor uses remote access to review the relevant data archived on the instrument.The events reported on this quarterly malfunction summary report are limited to those in which no patient harm occurred, and no design defect (or other systemic problem) was identified.There is no specific action that users are expected to take to mitigate the reported device failure/malfunction other than to ensure that preventative maintenance is performed as indicated in the instrument instructions.Immucor will continue to track and trend performance and operational issues such as described in this quarterly malfunction summary report.
Event or Problem Description
A review of quarterly events indicated that for twelve (12) patient/donor samples tested using the echo lumena automated blood bank system, a malfunction occurred resulting in the instrument producing incorrect results.A review indicated that nine (9) patient samples and three (3) donor samples tested using the echo lumena automated blood bank system produced inaccurate results: a missed anti-c and anti-e for one (1) patient sample during an antibody screen; a missed anti-e for one (1) patient sample during an antibody id; a missed anti-fya for one (1) patient sample during an antibody screen; a missed anti-fya for one (1) patient sample during an antibody id; a missed anti-jsa for one (1) patient sample during an antibody id; a missed anti-fya and anti-kell for one (1) patient sample during an antibody screen; a missed anti-kell for one (1) patient sample during an antibody screen; a missed unspecified antibody for one (1) patient sample during an antibody screen; a missed anti-jka for one (1) patient sample during an antibody screen and antibody id; a missed anti-e for one (1) patient sample during an antibody screen and antibody id; and unexpected abo typing results for three (3) donor samples.
Additional Manufacturer Narrative
No common specific root cause or defect was identified.The conclusion(s) code(s) reported herein are assigned according to the facts presented by the affected customer and immucor's assessment and investigation of those facts.When possible, immucor attempts to obtain the actual samples and reagents involved; retention reagents of the same lot that was involved in the event may be used during the investigation if indicated.Also, when possible, immucor uses remote access to review the relevant data archived on the instrument.The events reported on this quarterly malfunction summary report are limited to those in which no patient harm occurred, and no design defect (or other systemic problem) was identified.There is no specific action that users are expected to take to mitigate the reported device failure/malfunction other than to ensure that preventative maintenance is performed as indicated in the instrument instructions.Immucor will continue to track and trend performance and operational issues such as described in this quarterly malfunction summary report.Three additional events (pr#(b)(4).Were determined to be reportable after the initial quarterly malfunction summary report had been submitted; these events were initially assessed as not reportable, but upon subsequent review were determined to be reportable.This corrected quarterly malfunction summary report has been submitted in response to the agency's december 27, 2024 email (gen2400785-s002: request of corrections of mdrs submitted in summary format).

• Brand Name: ECHO LUMENA
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• MDR Report Key: 20579146
• Report Number: 1034569-2024-00017
• Device Sequence Number: 8096336
• Product Code: KSZ
• UDI-Device Identifier: 10888234002338
• UDI-Public: 10888234002338
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: BK070016
• Exemption Number: VMSR
• Number of Events Summarized: 10
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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