GTI TEST KITS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-23 for GTI TEST KITS manufactured by Gti Diagnostics.

Event Text Entries

[1686756] The gti test kit is used to determine hit antibodies. However, it has been learned that the test kit is giving false positives as confirmed by the blood ctr of (b)(6). Gti does not feel this is clinically significant and recommends if there is a question to purchase gti's confirmation kits. However, the question then becomes what do you do if you get what you believe is a false positive, use gti's confirmation kit and get a negative result. This is not a satisfactory solution where it is believed there is a product giving false positives. Our blood bank physician can provide much more detailed info if desired. The local solution is that if gti's test is negative, then no further action. If there is a positive test using gti's kit, another sample will be sent to the blood ctr of (b)(6) for verification. This is not an optimal solution but the only one we feel comfortable with at the present time. Diagnosis or reason for use: hit testing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5018711
• MDR Report Key: 1942098
• Date Received: 2010-12-23
• Date of Report: 2010-12-23
• Date of Event: 2010-12-17
• Date Added to Maude: 2011-01-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GTI TEST KITS
• Generic Name: GTI TEST KITS
• Product Code: MYP
• Date Received: 2010-12-23
• Lot Number: 031710-X45
• Device Expiration Date: 2012-02-03
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GTI DIAGNOSTICS

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-12-23