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

Model Number	628915
Medical Device Problem Codes	Incorrect Measurement (1383); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported a mistyped sample for lifecodes hla-b sso typing kit lot 3008083, sample id (b)(4), tested on (b)(6) 2020.The results on the first run were (b)(6).There were many failed samples (7 out of 10) during this run which led the user to re-read the assays.Additionally the sample in question had failed amplification for hla-a and hla-c loci.The customer did not run a positive control with the assay.A new sample was obtained and tested along with the original sample on (b)(6) 2020.The typing was (b)(6) for both the original and new sample.This result, for the repeat testing of the original sample and a new sample has been corrected to the original report.Prior to the second testing events, the customer performed maintenance on the luminex instrument.Due to the original testing event encountering 7 of 10 samples as having failed amp (not including the sample in question), this may be indicative to technical error during testing.The nature of the error cannot be determined from the raw data.The customer has been informed to run a positive control and when reviewing samples to check for common haplotypes.Within the ifu, it is recommended to include one negative and positive control.Values are included in the ifu for consensus probes to exceed values set forth in product labeling.There is no harm known or expected to the patient due to the first result reporting.Complaint id# (b)(4).

• Brand Name: LIFECODES HLA-B SSO TYPING KIT
• Common Device Name: TEST, QUALITATIVE, FOR HLA, NON-DIAGNOSTIC
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 10868731
• Report Number: 2183608-2020-00001
• Device Sequence Number: 2465337
• Product Code: MZI
• UDI-Device Identifier: 10888234400028
• UDI-Public: 10888234400028
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: BK130075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2020

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: 01/15/2021
• Device Model Number: 628915
• Device Catalogue Number: 628915
• Device Lot Number: 3008083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1