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

Catalog Number	0087000
Medical Device Problem Codes	False Negative Result (1225); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes malfunction events.A review of the events indicated that three (3) patient sample tests using the echo automated blood bank system produced unexpected negative results for specific antibodies.The results represent false negatives due to prior patient histories or, testing completed by other methods that demonstrated the presence of the specific antibodies.The malfunction did not show positive results as expected for the anti-e antibody on one (1) occasion when using the capture r ready id reagent.The malfunction did not show positive results as expected for the anti-c antibody on one (1) occasion when using the capture r ready id reagent.When the customer adjusted the well residual volume (wrv) the sample results were as expected.The malfunction did not show positive results as expected for the anti-jka antibody on one (1) occasion when using the capture r ready screen 3 reagent.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 30091 5625
• MDR Report Key: 9252159
• Report Number: 1034569-2019-00144
• Device Sequence Number: 1960296
• Product Code: KSZ
• UDI-Device Identifier: 10888234001584
• UDI-Public: 10888234001584
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/29/2019

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 Catalogue Number: 0087000
• Device Lot Number: ID387,R070
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Periodic
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1