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

Model Number	628913
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint ((b)(4)) was received on november 17, 2020 from a customer in france describing that lifecodes hla-a eres sso typing with lot 3008199 and imgt 3.39 resulted in typing a*03:01, a*68:02.The lab also tested with an alternate vendor product; ngs (omixon) with a result of a*03:01,a*68:187.Per lifecodes hla-a eres sso typing results, the a*68:187 as obtained with the ngs method is not present.Sample id: (b)(6).Lot #: 3008199.Catalog #: 628913.Customer has been requested to provide dna sample to allow testing to confirm or negate the complaint.
Event or Problem Description
The root cause of the mistyping was a limitation of the assay for rare ambiguities.Immucor gti diagnotics inc.Makes no claims that our tests are comparable to next-generation sequencing (ngs).In addition the following description is included in the ifu (lc1436ivden rev.K): "results from these kits are not to be used as the sole basis upon which a clinical decision affecting the patient is made.".

• Brand Name: LIFECODES HLA-A 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: 11022134
• Report Number: 2183608-2020-00002
• Device Sequence Number: 753490
• Product Code: MZI
• UDI-Device Identifier: 10888234400011
• UDI-Public: 10888234400011
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: BK130075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 02/15/2021
• Device Model Number: 628913
• Device Catalogue Number: 628913
• Device Lot Number: 3008199
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1