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

Model Number	0086998
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2021 an immucor field service engineer (fse) visited the site to inspect echo lumena instrument serial number (b)(4).The fse reviewed the unexpected results reported on the system and successfully performed an unexpected reaction checklist.All systems were within specs and no instrument problems were observed.The immucor internal record number for this report is pr# (b)(4).
Event or Problem Description
On (b)(6) 2021 a customer reported that an oncology patient tested negative with capture-r ready-screen 3 on the echo lumena instrument on (b)(6) 2021.Patient had been treated with daratumumab (which masked the antigens and created a false negative result).On (b)(6) 2021 the patient started to experience a transfusion reaction and went to another hospital for treatment.

• Brand Name: ECHO LUMENA
• Common Device Name: AUTOMATED BLOOD BANK ANALYZER
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30071
• MDR Report Key: 12041414
• Report Number: 1034569-2021-00018
• Device Sequence Number: 11629148
• Product Code: KSZ
• UDI-Device Identifier: 10888234002338
• UDI-Public: 10888234002338
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: BK200483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0086998
• Device Catalogue Number: 0086998
• Device Lot Number: M20284
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1