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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. GALILEO NEO; AUTOMATED BLOOD BANK SYSTEM
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IMMUCOR, INC. GALILEO NEO; AUTOMATED BLOOD BANK SYSTEM Back to Search Results
Catalog Number 0064599
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/25/2017
Event Type  malfunction  
Manufacturer Narrative
Immucor technical support used a remote electronic connection method on (b)(6) 2017 to assess the instrument test well image in question, which appeared visually negative.
 
Event Description
On (b)(6) 2017, a customer reported an unexpected abo blood type antigen mistype, when tested on a galileo neo.
 
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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 Key6623161
MDR Text Key77311535
Report Number1034569-2017-00111
Device Sequence Number1
Product Code KSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BK100033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Medical Technologist
Type of Report Initial
Report Date 06/08/2017
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 Number0064599
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/25/2017
Initial Date FDA Received06/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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