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 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols laboratory solutions for dna sequencing.Next generation sequencing interrogated rh genes proximal promoter, exons 1-10, and portions of intron 2-3.A hybrid rhce allele containing rhd exons 2 and 3 was found in rhce gene, and sequencing provided the genotype rhce*ce (rhce*01), rhce*ce-d(2-3)-ce.However, id core xt reported the genotype as rhce*ce.Id core xt determines the presence of c antigen by interrogating the polymorphism c.335+3039ins109 in rhce gene intron 2.The extent of the rhd exon 2-intron 2-exon 3 sequence includes the replacement of rhce*c intron 2 sequence and explains the failure of id core xt to predict a c+ phenotype.Id core xt predicted a c- phenotype, but the serological data indicated a c+ phenotype, attributable to the presence of the rare rhce*ce-d(2-3)-ce allele.This id core xt false negative result is considered a discrepant result and then a malfunction.Nevertheless, further serological investigation is recommended to fully characterize this unreported hybrid allele.This limitation is covered by the assay limitations described in the id core xt package insert limitations 1 and 9.

Event Description

It was reported that the sample (b)(6), from "(b)(6)", was tested with serology.The test result was positive (c+), which contrasted with the molecular typing performed on (b)(4) 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: 18812843
• MDR Text Key: 337633028
• Report Number: 3006413195-2024-00007
• 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