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

Catalog Number 0064599

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

Immucor technical support used a remote electronic connection method on (b)(6) 2017 to assess the instrument test well images in question, which showed that the test well images associated with the blood sample in question were consistent with the erroneous overall instrument output.An immucor field service engineer (fse) visited the customer site on 27apr2017 to assess the instrument in question.The fse found a discolored area in the tubing of sample probe 1, and subsequently replaced that probe.From a root cause analysis perspective, as probable user error, the customer most likely hand-scanned the wrong blood sample barcode in the instrument sample loading bay before running the assay.However, this theory cannot be categorically proved in this instance.Therefore, these two (2) blood samples are to be reported ((b)(6)).

Event Description

On (b)(6) 2017, a customer reported an unexpected combined abo and rh (d) blood type antigen mistype, when tested on a galileo neo.

• Brand Name: GALILEO NEO
• Type of Device: AUTOMATED BLOOD BANK SYSTEM
• 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: 6552339
• MDR Text Key: 74893511
• Report Number: 1034569-2017-00090
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234001041
• UDI-Public: 10888234001041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK100033
• 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: 05/08/2017

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 Catalogue Number: 0064599
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2013
• 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
• Patient Age: 45 YR