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

Catalog Number 1021920000

Device Problem False Positive Result (1227)

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols laboratory solution for dna sequencing of rh proximal promoter, exons 1-10 and portions of intron 2-3.One rhce nonfunctional allele was identified, rhce*ce(488_489del) associated with null rhce (non-expression of rhce antigens), which id core xt does not interrogate.Id core xt detected a heterozygous functional allele rhce*ce, rhce*ce and predicted a false positive e+.These false positive results obtained by id core xt are considered discrepant results and then a malfunction.This case report is associated with limitations of id core xt assay, as described in the id core xt package insert (sec 1 and 10 assay limitations).

Event Description

It was reported that the sample (b)(6), from secretaria da saude do estado do ce, was tested with serology.The test result was negative (e-), which contrasted with the molecular typing performed on 12sep23, using the id core xt assay which provided positive results (e+) 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: 18630756
• MDR Text Key: 335416974
• Report Number: 3006413195-2024-00002
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 08437013457590
• UDI-Public: (01)08437013457590(17)240724(10)0203000031
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1021920000
• Device Lot Number: 0203000031
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• 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