MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. LIFECODES HLA-DQA1/B1 SSO TYPING KIT

Catalog Number	628930
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Customer contacted immucor technical support (complaint #(b)(4)) that samples on the lifecodes hla-dqa1/b1 sso typing kit (628930), lot # 3004970 had discrepant results.Sample was resulting as dqb1*06:09:01:01 homozygous.It was subsequently identified that the sample was not homozygous but found to be dqb1 *06:09:01:01, *03:03:02:01.The customer was not following the product instructions for use (ifu).The customer was not using full volumes of reagents.The customer identified the issue because the obtained results did not fit with the hla-dr associations they should match.The customer repeated the testing with an alternate method (ssp) and discovered a hla-dq6, dq3 result rather than the hla-dq6 homozygote.The customer informed immucor that they performed an investigation to check for patient harm but have found no cause for patient harm.Customer is not following the ifu and was aware of potential risks involved in doing this.

• Brand Name: LIFECODES HLA-DQA1/B1 SSO TYPING KIT
• Common Device Name: LIFECODES HLA-DQA1/B1 SSO TYPING KIT
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 7716242
• Report Number: 2183608-2018-00023
• Device Sequence Number: 16410427
• Product Code: MZI
• UDI-Device Identifier: 10888234400462
• UDI-Public: 10888234400462
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: BK150302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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: Health Professional
• Device Expiration Date: 06/15/2018
• Device Catalogue Number: 628930
• Device Lot Number: 3004970
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1