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

Catalog Number 0089000

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2017

Event Type  malfunction  

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 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
• Type of Device: COATED MIC.TYPING PLATES FOR USE IN HEMAGG. ASSAYS IMMUCOR AUTOMATED INSTRUMENTS
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer (Section G): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• Manufacturer Contact: howard yorek ; 3130 gateway drive; norcross, GA 30091-5625 ; 7704412051
• MDR Report Key: 6630318
• MDR Text Key: 77449170
• Report Number: 1034569-2017-00112
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234001591
• UDI-Public: 10888234001591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA FOR CMT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 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
• Device Operator: Medical Technologist
• Device Expiration Date: 03/15/2018
• Device Catalogue Number: 0089000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1