MAUDE Adverse Event Report: IMMUCOR GTI DIAGNOSTICS, INC. LIFECODES HLA-DQA1/B1 SSO TYPING KIT

Catalog Number	628930
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Codes	No Information (3190); Missing Value Reason (3192)
Date of Event	01/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Customer contacted immucor on (b)(6) 2018 ((b)(4)) regarding a sample in which an allele dropout was suspected with lifecodes hla-dqa1/b1 sso typing kit lot 3004970.The sample was tested and originally resulted in a dqb1 typing of dq5 homozygous with an exact match by the software.The customer suspected a possible allele dropout with the sample and retested the sample with sequence-specific primer (ssp).This resulted in a dqb1 heterozygous typing of dq5/dq9.The sample was then retested by lifecodes sso, resulting in a review probes prompt by the software.The sample required two manual bead changes to result in the heterozygous typing dq5/dq9.The customer stated that they follow immucor product storage and ifu protocols.The incorrect typing was not reported out by the customer.The sample was repeated and the correct results reported out.The customer decided to repeat the sample testing by both ssp and sso due to known gene linkages and also because what the customer considers false negative dq3 probes, were within 30% range from threshold for the sample.The customer will continue to monitor this issue.

• Brand Name: LIFECODES HLA-DQA1/B1 SSO TYPING KIT
• Common Device Name: LIFECODES HLA-DQA1/B1 SSO TYPING KIT
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 7707535
• Report Number: 2183608-2018-00004
• Device Sequence Number: 10912683
• Product Code: MZI
• UDI-Device Identifier: 10888234400462
• UDI-Public: 10888234400462
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BK150302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2018

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: No Information
• Device Expiration Date: 06/15/2018
• Device Catalogue Number: 628930
• Device Lot Number: 3004970
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1