MAUDE Adverse Event Report: IMMUCOR, INC. GALILEO NEO; AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEMS

Catalog Number 0064599

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019 immucor technical support used a remote electronic connection method to assess files on galileo neo instrument serial number (b)(4); roi's were acceptable and no errors were seen during times of testing.On (b)(6) 2019 an immucor field service technician inspected galileo neo instrument serial number (b)(4) at the customer facility.The technician found the instrument operational and performed a successful unexpected reaction checklist.Found instrument to be fully operational and to be operating in specification.Customer was informed that unable to rule out the possibility that the original vials of anti-d (monoclonal blend) series 4 and anti-d (monoclonal blend) series were compromised.The immucor internal report record number for this report is (b)(4).

Event Description

On (b)(6) 2019 a customer reported rh discrepancies when testing donor samples on the galileo neo instrument.

• Brand Name: GALILEO NEO
• Type of Device: AUTOMATED BLOOD GROUPING AND ANTIBODY TEST SYSTEMS
• 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: 8860787
• MDR Text Key: 209446464
• Report Number: 1034569-2019-00125
• 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: BK190337
• 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: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0064599
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2015
• 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