MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. LIFECODES HLA-CERES SSO TYPING KIT

Model Number	628921
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	07/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint ((b)(4)) was received on (b)(6) 2017, where the customer reported that lifecodes hla-ceres sso typing kit (lot 08056c) gave a result that was not concordant with sequence based typing.The clinical sample gave the following when tested with sequence based typing: hla-c (c*01:115, c*04:01).This result was not consistent with the result obtained when the sample was tested with lifecodes hla-ceres lot 08056c 12/10/2020 (b)(4).Notification from fda was received on november 27, 2020 notifying immucor gti diagnostics that this initial report was not received whereas a follow up 2 report was.Submission of this report is being provided per direction received.
Event or Problem Description
(b)(6) follow-up 2 to correct date of report and date received.
Event or Problem Description
Refer to initial report submitted on 08/24/2017.(b)(6) 2020: notification from fda was received on november 27, 2020 notifying immucor gti diagnostics that this follow-up report was not received whereas a second follow-up was received.Submission of this report is being provided per direction received.

• Brand Name: LIFECODES HLA-CERES SSO TYPING KIT
• Common Device Name: LIFECODES HLA-CERES SSO TYPING KIT
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• Manufacturer (Section G): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• Manufacturer Contact: erika hewitt ; 20925 crossroads circle; waukesha, WI 53186 ; 2627541006
• MDR Report Key: 7542139
• Report Number: 2183608-2017-00003
• Device Sequence Number: 1265502
• Product Code: MZI
• UDI-Device Identifier: 10888234400059
• UDI-Public: 10888234400059
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2017

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 Expiration Date: 08/31/2017
• Device Model Number: 628921
• Device Catalogue Number: 628921
• Device Lot Number: 08056C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 08/29/2017; 08/29/2017
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 12/29/2020; 05/24/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown