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

Catalog Number 0064999

Device Problem False Positive Result (1227)

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

Event Date 09/30/2018

Event Type  malfunction  

Manufacturer Narrative

An immucor field service engineer (fse) visited the customer site to assess the instrument in question on (b)(6) 2018, and found the instrument to be operating as expected.The customer faxed the instrument reports to immucor technical support, which were assessed by technical support.The fse found no additional errors when the instrument log was checked.(b)(4).

Event Description

On (b)(6) 2018, a customer site reported to immucor technical support an unexpected abo blood group mistype when tested on a galileo instrument on (b)(6) 2018.

• Brand Name: GALILEO
• 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: 8014361
• MDR Text Key: 126375554
• Report Number: 1034569-2018-00240
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK040013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2018

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: No Information
• Device Catalogue Number: 0064999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2007
• 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