MAUDE Adverse Event Report: IMMUCOR, INC. CMT PLATES; COATED MIC.TYPING PLATES FOR USE IN HEMAGG. ASSAYS IMMUCOR AUTOMATED INSTRUMENTS

Catalog Number	0089000
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immucor technical support used a remote electronic connection method on (b)(4) 2017 to assess the instrument test well image in question, which appeared visually positive.
Event or Problem Description
On (b)(6) 2017, a customer reported an unexpected abo blood type antigen mistype, when tested on a galileo echo, when using cmt plates.

• Brand Name: CMT PLATES
• Common Device Name: COATED MIC.TYPING PLATES FOR USE IN HEMAGG. ASSAYS IMMUCOR AUTOMATED INSTRUMENTS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 6630318
• Report Number: 1034569-2017-00112
• Device Sequence Number: 625005
• Product Code: KSZ
• UDI-Device Identifier: 10888234001591
• UDI-Public: 10888234001591
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: NA FOR CMT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

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: Medical Technologist
• Device Expiration Date: 03/15/2018
• Device Catalogue Number: 0089000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1