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

Model Number 0086998

Device Problems False Negative Result (1225); False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This report summarizes malfunction events.A review of the events indicated that five (5) patient sample tests using the echo lumena automated blood bank system produced rh mistypes and unexpected results for antibody screenings.Three malfunctions showed rh mistypes using the anti-d series 4 reagent.A single malfunction occurred by producing an unexpected false negative for anti-c using the capture r ready screen 3 reagent.A single malfunction occurred by producing a false negative for anti-k.Subsequent testing of reagent retention lots, reviews of design history records and reagent antigen validation testing of the initial bulk product used for commercial vialing showed acceptable results.Through post event tests and investigations, no specific causes were determined for the malfunctions.

• Brand Name: ECHO LUMENA
• Type of Device: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross, ga
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross, ga
• Manufacturer Contact: howard yorek ; 3130 gateway drive; norcross, ga ; 4412051473
• MDR Report Key: 10346530
• MDR Text Key: 206953681
• Report Number: 1034569-2020-00047
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234002338
• UDI-Public: 10888234002338
• Combination Product (y/n): N
• PMA/PMN Number: BK070016
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0086998
• Device Catalogue Number: 86998
• Device Lot Number: 924660,504868
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1