MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. DONORSCREEN-HLA CLASS I AND CLASS II; TEST, HLA PRODUCT CODE: MZI

Catalog Number	DSI+II
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The donorscreen-hla class i and class ii assay is used by a laboratory group, (b)(4) which has several sites in the united states.Cts reported an hla class ii result discrepancy between testing performed at 2 sites, (b)(4).The sample was a fresh sample, never frozen, drawn on (b)(6) 2018 in 2 seperate tubes which was refrigerated until (b)(6) 2018 for testing.Testing was performed on (b)(6) 2018.The testing was performed at both sites about an hour apart.Discrepancy in results for two samples between the sites was reported.There is conflict in the information from the customer where the customer stated one sample was affected but data and some description provided by customer is that two samples were affected.The hla class i results were negative for the samples at both sites.Site: quickstep serial #: sample id: result: result reported kit lot #: 1, (b)(4) , (b)(4) - ( neg), no, 3006245a/b.2, (b)(4), (b)(4) + (pos), yes, same.1, (b)(4), (b)(4) - ( neg), no, same.2, (b)(4), (b)(4) + (pos), yes, same.The customer stated that their qa department determined the pos (positive) result would be reported for this sample.Four contacts with the customer who placed the complaint were attempted.As of this report, response has still not been received from the contact at the customer site.

• Brand Name: DONORSCREEN-HLA CLASS I AND CLASS II
• Common Device Name: TEST, HLA PRODUCT CODE: MZI
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 7542214
• Report Number: 2183608-2018-00012
• Device Sequence Number: 13840613
• Product Code: MZI
• UDI-Device Identifier: 10888234500193
• UDI-Public: 10888234500193
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK070045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

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
• Operator of Device: Medical Technologist
• Device Expiration Date: 08/15/2019
• Device Catalogue Number: DSI+II
• Device Lot Number: 3006245A/B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1