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

Catalog Number	888623
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The (b)(6) has reported a complaint ((b)(4)) on (b)(6) 2017 that when using match it! dna software v1.2.3 for hla-a typing, they have observed for 1 sample that the software does not correctly load the suggested assignment table when navigating between samples that contain complex numbers of hla-a allele-string pairs (observed with hla-a*02 homozygous samples).The error occurs when using pairwise off with a win 7 32-bit computer, using 3.27 allele database.When the user navigates from one sample to the next sample, the software does not automatically assign a typing into the assigned view field when the auto assign feature is activated in preferences.If the user attempts to make a manual assignment to the assigned view field, the software will crash.During the course of the investigation with the customer, the user's software was updated from v1.2.3 to v1.2.4.An error still occurs in v1.2.4, however in this version the when the user navigates from one sample to the next sample, the software maintains the previous sample typing in the assigned view in addition to the suggested assignments.If the user attempts to make a manual assignment, the software will freeze however there is no warning that the typing in assigned view is incorrect.
Event or Problem Description
The nhsbt has reported a complaint (b)(4).On (b)(6) 2017 that when using match it! dna software v1.2.3 for hla-a typing, they have observed for 1 sample that the software does not correctly load the suggested assignment table when navigating between samples that contain complex numbers of hla-a allele-string pairs (observed with hla-a*02 homozygous samples).The error occurs when using pairwise off with a win 7 32-bit computer, using 3.27 allele database.When the user navigates from one sample to the next sample, the software does not automatically assign a typing into the assigned view field when the auto assign feature is activated in preferences.If the user attempts to make a manual assignment to the assigned view field, the software will crash.During the course of the investigation with the customer, the user's software was updated from v1.2.3 to v1.2.4.An error still occurs in v1.2.4, however in this version when the user navigates from one sample to the next sample, the software maintains the previous sample typing in the assigned view in addition to the suggested assignments.If the user attempts to make a manual assignment, the software will freeze however there is no warning that the typing in assigned view is incorrect.1012208 jae: a field action (product correction), fa-wks-18-005 was performed to notify customers of the software issues.The field action is considered complete as of (b)(6) 2018.

• Brand Name: MATCH IT! DNA SOFTWARE
• Common Device Name: MATCH IT DNA SOFTWARE
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha 53186
• MDR Report Key: 7207186
• Report Number: 2183608-2018-00001
• Device Sequence Number: 19091670
• Product Code: MZI
• UDI-Device Identifier: 10888234400394
• UDI-Public: 10888234400394
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: BK150343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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: Other
• Device Catalogue Number: 888623
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 10/12/2018
• 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: B-0347-0348-2018
• Patient Sequence Number: 1