MAUDE Adverse Event Report: IMMUCOR, INC. ECHO V 2.0; AUTOMATED BLOOD BANK SYSTEM

Catalog Number	0087000
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support verbally communicated with the reporter on (b)(6) 2019 to document the user's information.On (b)(6) 2019, pi tested retention cap r ready extend lot dp108 in manual capture using antisera qualified for manual capture testing, anti-fya lot dl17866a.Controls performed as expected and all fya positive cells tested resulted positive as expected.Retention product performed as expected.There are no additional complaints of unexpected negative reactivity noted on cap r ready extend lot dp108.There are no deviations or oos investigations associated with cap r ready extend lot dp108.Our investigation did not identify a product deficiency.Retention product performed as expected (b)(4).
Event or Problem Description
On (b)(6) 2019, customer reported an unexpected negative result for anti-fya using capture r extend i on an echo v 2.0 with one patient sample.

• Brand Name: ECHO V 2.0
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8862054
• Report Number: 1034569-2019-00127
• Device Sequence Number: 16601338
• Product Code: KSZ
• UDI-Device Identifier: 10888234000679
• UDI-Public: 10888234000679
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: BK170132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2019

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: No Information
• Device Catalogue Number: 0087000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR