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

Catalog Number	628930
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Immucor received a customer complaint on 26 february 2018 ((b)(4)) from a customer that contacted immucor regarding eight samples across three runs that generated a mistype with lifecodes hla-dqa1/b1 sso typing kit (lot 3006117).The customer reports that for these samples the dqa probe 207 was false negative resulting in dqa sample mistype for dqa1*02.In all cases, the samples were typed as dqa1*01 homozygous by lifecodes hla-dqa1/dqb1 sso typing kit lot 3006117.The samples were repeated for dqa locus by the customer on ssp/linkseq and the repeat typing results were dqa1*01, dqa1*02.The customer informed immucor that no incorrect results were reported.The customer chose to repeat the typings by another method due to probe 207 being close to the threshold and due to known gene associations with drb1.

• 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: 7542134
• Report Number: 2183608-2018-00010
• Device Sequence Number: 19195742
• 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): 02/26/2018

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: Other
• Device Expiration Date: 06/15/2019
• Device Catalogue Number: 628930
• Device Lot Number: 3006117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1