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

Catalog Number	628930
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Customer complaint ((b)(4)) was received 02may2017 via product distributor that customer is having issues with lifecodes hla-dqa1b1 sso typing kit (628930), lot 10205a.Customer reports that multiple indeterminate probes (weak reactivity), specifically beads 242, 274, 281, and 292 are noted as falling below the lot specific cut-off value.Per the product ifu, 2 probes may be indeterminate (falling below the lot specific cut-off value).For this assay, 4 probes were indeterminate, therefore invalidating the assay.It is not known if the customer recognized that this assay was invalid due to the 4 probes resulting as indeterminate.The customer performs the assay with several variations from the protocol described in the lifecodes hla-dqa1b1 sso typing kit ifu (instructions for use).Alternate method to prepare sample volume used in the assay, dna concentration is not quantified it is expected the range they use meets the assay defined range, alternate vendor amplification plates are used.Data provided by the customer points to issues with technique/equipment and not with kit.Additional questions asked of customer were not responded to.Root cause of weakly reactive probes in lifecodes dqab sso kit could not be determined from information received from distributor.Continued monitoring will be done.No further actions are required.

• 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: 7720742
• Report Number: 2183608-2018-00020
• Device Sequence Number: 19149816
• Product Code: MZI
• UDI-Device Identifier: 10888234400462
• UDI-Public: 10888234400462
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: BK150302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2017

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: No Information
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 628930
• Device Lot Number: 10205A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2017
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1