MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. LIFECODES HLA-DPA1/B1 SSO TYPING KIT; LIFECODES HLA SSO TYPING KIT

Model Number	628936
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
12/16/2020 ac notification from the fda was received on november 27, 2020 notifying immucor gti diagnostics that this initial report was not received whereas follow up 2 report was.Submission of this report is being provided per direction received.Before submission, report was reviewed and updated as needed.A complaint ((b)(4)) was received from (b)(6) on june 7, 2017.The lifecodes hla-dpa1/b1 typing kit (lot number 12085a, expiration 2017-10-31) mistyped a patient sample due to incorrect assignment for probe 302.The sample was also tested using a high resolution dna typing method, which generated the result as dpb1*04:02, dpb1*46:01.Probe 302 resulted as positive.Probe 302 would need to be negative in order to obtain the same result as the high resolution dna typing result.The customer was performing validation testing of the lifecodes hla-dpa1/b1 typing kit.Investigation of the complaint identified that the reason for the incorrect result was due to unknown sequence for probe 302 with dqb1*46*01 while using allele database (version (b)(4)).As part of a further investigation, allele database version (b)(4) was reviewed.It was determined that the probe hit charts and allele database files for version (b)(4) were incorrect.These files are used with the matchit! dna software.No patient harm has been reported.This report is being provided due to the possibility if further events occurred, it is possible that incorrect results may be generated with this and other kits from the lifecodes hla sso kit product family.Hla (human leukocyte antigen) allele characterization and specificity are expanded over time.As new alleles are identified or rare alleles are further characterized, updates to how the molecular probes in the lifecodes sso typing kits react are needed.The probe hit charts and the allele database files which are provided as lot specific interfaces to the matchit! dna software, are updated as the new information is available.For the recent updates, it was further identified that the source (imgt database) of the information changed the method in which the information was provided to immucor.When the updates were made to generate the new probe hit charts and allele database files, some of the updates were not successfully applied.The following products were identified to be affected.Product name lot #/serial # list #/part # expiration date lifecodes hla-dpa1/b1 sso typing kit 12085a, (b)(4), 31 oct 2017; lifecodes hla-dpa1/b1 sso typing kit 3004756, (b)(4), 15 sept 2018.
Event or Problem Description
(b)(6) follow-up #2 to correct date of event, date of report, date received.
Event or Problem Description
12/16/2020 ac.Notification from fda was received on november 27, 2020 notifying immucor gti diagnostics that this follow up report was not received whereas follow up 2 report was.Submission of this report is being provided per direction received.07-21-2017 follow-up-report to remove one of the product codes that was not applicable to this notification.

• Brand Name: LIFECODES HLA-DPA1/B1 SSO TYPING KIT
• Common Device Name: LIFECODES HLA SSO TYPING KIT
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha, wi WI 53186
• Manufacturer (Section G): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• Manufacturer Contact: joan rixe ; 20925 crossroads circle; waukesha, WI 53186 ; 2627541016
• MDR Report Key: 7542137
• Report Number: 2183608-2017-00002
• Device Sequence Number: 11516452
• Product Code: MZI
• UDI-Device Identifier: 10888234400479
• UDI-Public: 10888234400479
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: BK150302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Medical Technologist
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2017

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: 10/31/2017
• Device Model Number: 628936
• Device Catalogue Number: 628936
• Device Lot Number: 12085A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/20/2017; 07/20/2017
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 12/23/2020; 05/24/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown