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

Catalog Number 0087000

Device Problem False Positive Result (1227)

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

Event Date 04/14/2019

Event Type  malfunction  

Manufacturer Narrative

On april 15, 2019 immucor technical support used a remote electronic connection method to assess files on galileo echo instrument serial number (b)(4) to review data and image files; no problems were noted.On april 24, 2019 an immucor field service engineer (fse) inspected the instrument at the customer site.The fse completed annual preventative maintenance with no issues identified by fse w/ passing acceptable results.Fse was able to successfully verify instrument was performing in specification as echo preventative maintenance form was completed without issue.No issues were identified with echo and instrument continues to operate as intended.(b)(4).

Event Description

On april 15, 2019 a customer reported an rh discrepancy (unexpected positive) on a galileo echo instrument.

• Brand Name: GALILEO ECHO
• 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: 8608670
• MDR Text Key: 189243842
• Report Number: 1034569-2019-00094
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10888234001584
• UDI-Public: 10888234001584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK180220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0087000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2014
• 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: 27 YR