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

Catalog Number	628915
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2017, customer called technical support with complaint (b)(4) reporting that the mi dna software is calling b*08:04, 51:01, while ssp, sequence specific primer assay (alternate assay) shows b*08:01, 51:01 result.The customer was performing the assay as described in the instructions for use.The complaint is pertinent to the assay, not the software, specifically lifecodes hla-b sso typing kit (628915), lot 06036a.Three assay files were provided.The probes in question were probes 204, 207, 218, 296 which resulted with borderline reactivity.Probe 207 was overridden with result determined to be b*08:04, 51:01.Adjustment to overridden probes result in alternate identification for the 08 allele, either b08:04, b08:65, b 08:23 or b08:01.The csv files obtained from the customer were reviewed including allele comparison in the software and confirmed that when probes 204, 207 and 218 are negative the typing is b*08:01, 51:01.All three probe are within the 10% of the cutoff.This retyping matches ssp results.The 08:04, 08:65, 08:23 have one mismatch different from 08:01 reference.The rest of the sequence is identical for all four alleles.This explains why there is not a unique probe for 08:01 and due to the mismatches we have unique probes for 08:04, 08:65, 08:23.All other positive probes are common for all four alleles.Results were initially reported as b08:04, 51:01.The customer confirmed the results by ssp due to the borderline reactivity for the 4 identified probes.A revised result report of b08:01, 51:01 was provided.There was no patient harm reported.The assay is performing as expected, control values were within specifications.The customer acknowledged the similarity of these three probes 204, 207 and 218 and concur that a secondary method is needed when any of these probes run too close to the cutoff.An examination of complaints from april 13, 2016 to april 13, 2017 did not identify additional complaints for different results between the ssp and the sso typing kits.No trend is seen.Continued monitoring will be done.

• Brand Name: LIFECODES HLA-B SSO TYPING KIT
• Common Device Name: LIFECODES HLA-B SSO TYPING KIT
• Manufacturer (Section D): IMMUCOR GTI DIAGNOSTICS, INC.; 20925 crossroads circle; waukesha WI 53186
• MDR Report Key: 7719516
• Report Number: 2183608-2018-00019
• Device Sequence Number: 1015407
• Product Code: MZI
• UDI-Device Identifier: 10888234400028
• UDI-Public: 10888234400028
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BK130075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2017

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: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 628915
• Device Lot Number: 06036A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2017
• 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