MAUDE Adverse Event Report: PROGENIKA BIOPHARMA, S.A ID CORE XT; ANTIGEN GENOTYPING TEST

Catalog Number 1020220034

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols laboratory solutions for dna sequencing of rh promoter, exon 1-10, portions of introns 2-3.The variant rhce:c.335+3133a>g was identified on allele rhce*ce.The failure of id core xt to detect the 109-bp intron 2 associated with the rhce*c allele is due to the presence of rhce:c.335+3133a>g variant at the probe site.Id core xt reported a predicted c- phenotype, but rhce:c.335+3133a>g variant is associated with an allele drop-out.This false negative result obtained by id core xt is considered a discrepant result and then a malfunction.This limitation is covered by the general assay limitation described in the id core xt package insert limitations 1 and the specific limitation of this variant reported in limitation 9.1.

Event Description

It was reported that the sample (b)(6), from "centro de transfusión de la comunidad valenciana", was tested with serology.The test result was positive (c+), which contrasted with the molecular typing performed on (b)(6) 2023, using the id core xt assay which provided negative results (c-) with id core xt analysis software v3.0.2.

• Brand Name: ID CORE XT
• Type of Device: ANTIGEN GENOTYPING TEST
• Manufacturer (Section D): PROGENIKA BIOPHARMA, S.A; ibaizabal bidea, edificio 504; parque tecnologico de bizkaia; derio, bizkaia 48160 ; SP 48160
• Manufacturer Contact: jokin amo ; ibaizabal bidea, edificio 504; parque tecnologico de bizkaia; derio, bizkaia 48160 ; SP 48160
• MDR Report Key: 18812847
• MDR Text Key: 337632327
• Report Number: 3006413195-2024-00005
• Device Sequence Number: 1
• Product Code: PEP
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1020220034
• Device Lot Number: 0203000031
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1