MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. LIFECODES CLASS I ID

Catalog Number	628200
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint (b)(4) for lifecodes class i id (628200), lot # 3006385 was received on july 6, 2018.The customer reports pattern of positive results for historically negative patients when tested with class i id lot 3006385.The lab's sop requires that all samples are pre-treated with dtt (dithiothreitol) prior to testing.Customer has been informed that pre-treatment with dtt is not a validated process and is considered off-label use.Immucor technical support requested the customer run the samples neat (without pre-treatment).Customer stated that they will not perform any trouble-shooting at this time but would like immucor to address this issue in their manufacturing processes.Customer confirms no patient harm.Customer reported the results because the assay is not used as a standalone test.Significant changes in reactivity are verified by an alternate assay.Review of final product quality control (fpqc) testing was performed, product specifications were met.

• Brand Name: LIFECODES CLASS I ID
• Common Device Name: LIFECODES CLASS I ID
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 7736238
• Report Number: 2183608-2018-00027
• Device Sequence Number: 16836934
• Product Code: MZI
• UDI-Device Identifier: 10888234400295
• UDI-Public: 10888234400295
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: BK040035
• 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): 07/06/2018

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: Other
• Device Expiration Date: 01/15/2019
• Device Catalogue Number: 628200
• Device Lot Number: 3006385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1