MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. LIFECODES HLA-DRB1 SSO TYPING KIT

Catalog Number	628923
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	03/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2018 customer called in with complaint number (b)(4) to report failure for probes 007 and 008 for samples tested with lifecodes hla-drb1 sso typing kit.They report that in a single batch of 48 samples tested with dr1 sso typing kit (lot #04226a) probes 007 and 008 were negative for all samples.Tech support has contacted the distributor several times as of today with no response since june 1 when complaint was made.

• Brand Name: LIFECODES HLA-DRB1 SSO TYPING KIT
• Common Device Name: HLA-DRB1 SSO TYPING KIT
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 7650576
• Report Number: 2183608-2018-00025
• Device Sequence Number: 19441907
• Product Code: MZI
• UDI-Device Identifier: 10888234400066
• UDI-Public: 10888234400066
• Combination Product (Y/N): N
• PMA/510(K) Number: BK130075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 628923
• Device Lot Number: 04226A
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1