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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR, INC. GALILEO ECHO; AUTOMATED BLOOD BANK SYSTEM
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IMMUCOR, INC. GALILEO ECHO; AUTOMATED BLOOD BANK SYSTEM Back to Search Results
Catalog Number 0087000
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Information (3190)
Event Date 07/25/2017
Event Type  malfunction  
Manufacturer Narrative
No patient sample or customer product was returned to immucor for immucor investigation.Immucor technical support used a remote electronic connection method to assess the test well image in question on (b)(6) 2017, which appeared visually negative.
 
Event Description
On (b)(6) 2017, a (b)(6) customer reported obtaining an unexpected abo blood group mistype on the galileo echo.
 
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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 Key6794299
MDR Text Key83166125
Report Number1034569-2017-00199
Device Sequence Number1
Product Code KSZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
BK070016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Medical Technologist
Type of Report Initial
Report Date 08/15/2017
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 Number0087000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/25/2017
Initial Date FDA Received08/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2013
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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