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 Number2183608-2018-00029
MDR Report Key7830593
Report SourceDISTRIBUTOR,FOREIGN
Date Received2018-08-29
Date of Report2018-08-02
Date of Event2018-07-03
Date Mfgr Received2018-08-02
Device Manufacturer Date2017-03-24
Date Added to Maude2018-08-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS JULIE EWEND
Manufacturer Street20925 CROSSROADS CIRCLE
Manufacturer CityWAUKESHA WI 53186
Manufacturer CountryUS
Manufacturer Postal53186
Manufacturer Phone2627541009
Manufacturer G1IMMUCOR GTI DIAGNOSTICS, INC
Manufacturer Street20925 CROSSROADS CIRCLE
Manufacturer CityWAUKESHA WI 53186
Manufacturer CountryUS
Manufacturer Postal Code53186
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIFECODES HLA-C ERES SSO TYPING KIT
Generic NameLIFECODES HLA-C ERES SSO TYPING KIT
Product CodeMZI
Date Received2018-08-29
Catalog Number628921
Lot Number01317B
Device Expiration Date2019-01-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerIMMUCOR GTI DIAGNOSTICS, INC.
Manufacturer Address20925 CROSSROADS CIRCLE WAUKESHA WI 53186 US 53186


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-29

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