MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. LIFECODES HLA-B SSO TYPING KIT, LIFECODES HLA-B ERES SSO TYPING KIT; QUALITATIVE TEST FOR HLA, NON-DIAGNOSTIC

Catalog Number	628915
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complaint was received on march 2, 2018 ((b)(4)) describing that when reports were generated using product number 628915, lot number 01117a of lifecodes hla-b sso typing kit the serological equivalent for b*27:08 was shown to be bw4 rather than the correct bw6.Immucor gti diagnostics quality control reviewed the complaint and discovered that the change was due to a transcription error during creation of hla-b probe hit tables for 3.29.0 allele database serological equivalence file of the database files.The hla-b allele b*27:08 serological equivalence changed from a b27 (bw6) in allele database 3.27.0 to b2708 (bw4) in allele database 3.29.0.The hla-b allele b*27:08 serological equivalence was incorrectly assigned bw4.An ncr (ncr 1762) was opened to address the issue.Resolution of this error was made with a correction to the database, a customer notification (correction) and a technical update loaded to the immucor website for the affected lots of product.The serological equivalent (bw4 or bw6) is assigned by the world health organization (who).Lifecodes hla sso-b typing kit or lifecodes hla sso-beres affected kits: product name: lifecodes hla-b sso typing kit, lot#/serial #: 01117a, list # part#: 628915, expiration date: 2018-11-30; lifecodes hla-b sso typing kit, 06036a, 628915, 2018-05-31; lifecodes hla-beres sso typing kit, 01117b, 628917, 2018-12-31; lifecodes hla-beres sso typing kit, 06036b, 628917, 2018-12-31.The lifecodes hla sso-b and hla sso-b eres typing kits are meeting performance claims.This issue is a documentation error not associated with a performance claim or who standard.

• Brand Name: LIFECODES HLA-B SSO TYPING KIT, LIFECODES HLA-B ERES SSO TYPING KIT
• Common Device Name: QUALITATIVE TEST FOR HLA, NON-DIAGNOSTIC
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 7542142
• Report Number: 2183608-2018-00011
• Device Sequence Number: 13759352
• Product Code: MZI
• UDI-Device Identifier: 10888234400028
• UDI-Public: 10888234400028
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: BK130075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall,Other
• 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: Medical Technologist
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 628915
• Device Lot Number: 01117A
• 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: 03/02/2018
• 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