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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. FACTOR VIII ANTIBODY SCREEN
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IMMUCOR GTI DIAGNOSTICS, INC. FACTOR VIII ANTIBODY SCREEN Back to Search Results
Catalog Number F8S
Device Problem Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Event Date 11/27/2017
Event Type  malfunction  
Event Description
Customer complaint (b)(4) was received on (b)(6) 2017 for factor viii antibody screen (303283) lot 3004682.The customer reported that a (b)(6) year old male patient had factor viii antibody screen assay results that were negative, and the laboratory's bethesda assay results were positive (2.4 titer).Factor vii antibody screen assay results are also dependent on the progression of antibody formation as well as if/when fviii therapy is administered.The patient's course of therapy was not available from the laboratory.
 
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Brand Name
FACTOR VIII ANTIBODY SCREEN
Type of Device
FACTOR VIII ANTIBODY SCREEN
Manufacturer (Section D)
IMMUCOR GTI DIAGNOSTICS, INC.
20925 crossroads circle
waukesha WI 53186
Manufacturer (Section G)
IMMUCOR GTI DIAGNOSTICS, INC.
20925 crossroads circle
waukesha WI 53186
Manufacturer Contact
erika hewitt
20925 crossroads circle
waukesha, WI 53186
2627541006
MDR Report Key7706639
MDR Text Key114713193
Report Number2183608-2018-00002
Device Sequence Number1
Product Code GGP
UDI-Device Identifier10888234500001
UDI-Public10888234500001
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082205
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Physician
Type of Report Initial
Report Date 11/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date09/15/2018
Device Catalogue NumberF8S
Device Lot Number3004682
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/27/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age70 YR
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