LIFECODES HLA-C ERES SSO TYPING KIT 628921

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-08-29 for LIFECODES HLA-C ERES SSO TYPING KIT 628921 manufactured by Immucor Gti Diagnostics, Inc..

Event Text Entries

[118887672] Customer has reported (b)(4) to the technical sale specialist on (b)(6) 2018, during a routine visit that the hla-c allele assignments obtained using lifecodes hla-c eres sso typing kit (lot 01317b) for sample (b)(4) did not agree with the patient first dna sample assignment which was obtained using an alternate vendor kits back in 2015. The alleles assigned for sample (b)(4) on (b)(6) 2018 were hla-c*18:01 homozygous compared to hla-c*18:01, c*03:03 for the first sample by the alternate vendor's kit back in 2015. The customer indicated as part of their internal investigation, they repeated the sample using the above mentioned lot number and got similar results i. E. Hla-c*18:01 homozygous for sample (b)(4) and hla-c*18:01, c*03:03 heterozygous for the sample. As part of the same internal investigation sample (b)(4) was tested using pcr-ssp, hla sequencing assay, which gave hla-c*18:01, c*03:03 heterozygous assignment similar to the alternate vendor assignment back in 2015. Immucor technical support identified that the customer was using the product off label where set up of the assay was using a 1/2 volume protocol. The customer was advised to retest the sample using the standard protocol indicated in the ifu. The customer obtained the same results on the repeat testing, hla-c*18:01 homozygous when using the lifecodes hla-ceres sso typing kit. Immucor technical support reviewed the results sent for the second assay performed and although the run was technically valid, the mfi values of the consensus probes were almost half the values of the consensus probes of the other samples in the run. Dna concentration and purity was confirmed with the customer run and identified the customer was again using 1/2 volumes. A site visit was requested of the customer and the customer declined a visit from immucor field service. Immucor final product quality control records have been reviewed and confirmed that all qc specifications were met for final product and threshold testing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2183608-2018-00029
• MDR Report Key: 7830593
• Report Source: DISTRIBUTOR,FOREIGN
• Date Received: 2018-08-29
• Date of Report: 2018-08-02
• Date of Event: 2018-07-03
• Date Mfgr Received: 2018-08-02
• Device Manufacturer Date: 2017-03-24
• Date Added to Maude: 2018-08-29
• 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-C ERES SSO TYPING KIT
• Generic Name: LIFECODES HLA-C ERES SSO TYPING KIT
• Product Code: MZI
• Date Received: 2018-08-29
• Catalog Number: 628921
• Lot Number: 01317B
• Device Expiration Date: 2019-01-31
• 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		2018-08-29