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

Catalog Number	0089000
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support was unable to use a remote electronic connection method to assess files on galileo echo instrument serial number (b)(4).Customer practice is to remove two plates of cmt strips from pouch and put them on top of the echo before use; this is contrary to labeling and immucor technical service advised customer that strips should be stored in original pouch with desiccant.The immucor internal report record number for this report is (b)(4).
Event or Problem Description
On (b)(6) 2019 a customer reported receiving and unexpected negative when antigen typing a known positive sample on the galileo echo using cmt plates.

• Brand Name: CMT PLATES
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 8552615
• Report Number: 1034569-2019-00086
• Device Sequence Number: 400812
• Product Code: KSZ
• UDI-Device Identifier: 10888234001591
• UDI-Public: 10888234001591
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/30/2019
• Device Catalogue Number: 0089000
• Device Lot Number: NU044
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 61