MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. MATCH IT! DNA SOFTWARE

Model Number	888623
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Efs angers reported an error with a list of ambiguities with imgt 3.41 and matchit! dna software v1.3.They used matchit! dna software v1.3 according to the ifu.They compared the report for one sample ((b)(6)) in imgt 3.39 and imgt 3.41.The list of ambiguities is inexact, the list lost some of the allele combinations that were listed in the files.Upon investigation, it was discovered that alleles were being truncated on import of exp files.A sql function, utilfn_split, involved in the import is limiting the number of characters to 4000 characters.This affects the alleles that are imported into match it!, limiting the alleles for some loci.

• Brand Name: MATCH IT! DNA SOFTWARE
• Common Device Name: MATCH IT! DNA SOFTWARE
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 11404597
• Report Number: 2183608-2021-00002
• Device Sequence Number: 11648965
• Product Code: MZI
• UDI-Device Identifier: 10888234400394
• UDI-Public: 10888234400394
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: BK190439
• 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: Physician
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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 Model Number: 888623
• Device Catalogue Number: 888623
• Device Lot Number: 3007082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-WKS-21-001
• Patient Sequence Number: 1