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

Model Number	0087000
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 3 malfunction events.A review of the events indicated that three (3) patient samples tested on the echo automated blood bank system produced inaccurate results.A review indicated that one (1) patient sample test using the echo automated blood bank system produced an unexpected false negative result for the anti-k antibody.Two (2) instrument malfunctions produced an rh mistype with one sample producing an unexpected positive for anti-a and a second producing an unexpected positive for the b antigen during forward only abo typing; whereby, the result should have been a+ based on historical results.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
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross, ga
• MDR Report Key: 10016381
• Report Number: 1034569-2020-00035
• Device Sequence Number: 2462180
• Product Code: KSZ
• UDI-Device Identifier: 10888234001584
• UDI-Public: 10888234001584
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK070016
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 0087000
• Device Catalogue Number: 0087000
• Device Lot Number: NU225
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1