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

Catalog Number 1020220034

Device Problem False Positive Result (1227)

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

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols laboratory solution for sequencing.Dna sequencing interrogated gypb exons 1-2, 4-6 and pseudo-exon 3.The variant c.270+4t>c was found in gypb gene intron 5 resulting in a genotype gypb*03, gypb*04.06(270+4c).However, id core xt reported a genotype gypb*s, gypb*s.The rare gypb*04.06(270+4c) allele was previously associated to an s negative phenotype.Id core xt predicted an s+ phenotype, but the serological data indicated a s- phenotype, attributable to the presence of the rare gypb*04.06 (270+4c) allele.The id core xt false positive result 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 10).

Event Description

It was reported that the sample (b)(6), from "(b)(6)", was tested with serology.The test result was negative (s-), which contrasted with the molecular typing performed on 1(b)(6) 2023, using the id core xt assay which provided positive results (s+) 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: 18812864
• MDR Text Key: 337632264
• Report Number: 3006413195-2024-00009
• 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