LIFECODES HLA-B SSO TYPING KIT 628915

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-25 for LIFECODES HLA-B SSO TYPING KIT 628915 manufactured by Immucor Gti Diagnostics, Inc..

Event Text Entries

[115472996] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2183608-2018-00019
• MDR Report Key: 7719516
• Report Source: USER FACILITY
• Date Received: 2018-07-25
• Date of Report: 2017-03-31
• Date of Event: 2017-03-24
• Date Mfgr Received: 2017-03-31
• Device Manufacturer Date: 2016-05-17
• Date Added to Maude: 2018-07-25
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS JULIE EWEND
• Manufacturer Street: 20925 CROSSROADS CIRCLE
• Manufacturer City: WAUKESHA WI 53186
• Manufacturer Country: US
• Manufacturer Postal: 53186
• Manufacturer Phone: 2627541009
• Manufacturer G1: IMMUCOR GTI DIAGNOSTICS, INC.
• Manufacturer Street: 20925 CROSSROADS CIRCLE
• Manufacturer City: WAUKESHA WI 53186
• Manufacturer Country: US
• Manufacturer Postal Code: 53186
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LIFECODES HLA-B SSO TYPING KIT
• Generic Name: LIFECODES HLA-B SSO TYPING KIT
• Product Code: MZI
• Date Received: 2018-07-25
• Catalog Number: 628915
• Lot Number: 06036A
• Device Expiration Date: 2018-05-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: IMMUCOR GTI DIAGNOSTICS, INC.
• Manufacturer Address: 20925 CROSSROADS CIRCLE WAUKESHA WI 53186 US 53186

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-07-25