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 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols laboratory solution for dna sequencing.Next generation sequencing interrogated specific sequences: rh proximal promoter, exons 1-10, and portions of intron 2-3.The rh genotype detected by sequencing is a hybrid sequence of rhd exon2-intron2-exon3 within rhce gene.This hybrid sequence explains the failure of id core xt to detect the 109bp insert in intron 2 resulting in a false negative prediction of c antigen in discrepancy with serology result.The effect of this novel hybrid allele on rhce antigen expression is unknown and further review of serology data is recommended.This false negative result obtained by id core xt is considered a discrepant result and then a malfunction.This case report is associated with limitations of id core xt assay described in the id core xt package insert (limitations 1 and 9.7).

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: 17217759
• MDR Text Key: 318125115
• Report Number: 3006413195-2023-00015
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 08437013457064
• UDI-Public: (01)08437013457064(17)240207(10)0203000029
• 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: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2024
• Device Catalogue Number: 1020220034
• Device Lot Number: 0203000029
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• 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