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

Catalog Number	1021720000
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sample (b)(6), from "memorial blood center", 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 v3.0.4.1.
Additional Manufacturer Narrative
See section b6.
Additional Manufacturer Narrative
The genomic dna sample was sent to grifols laboratory solution for next generation sequencing (ngs) of the rh exons 1-10 and portions of introns 2 and 3.The allele rhce*diiia(1-2)-cevs.03 was identified.The intron 2 insert is not present indicating absence of the consensus rhce*ce allele as reported by id core xt.This new allele, not previously described by isbt, could be associated with partial c expression, in agreement with the reported c+ serotyping.Id core xt reported a predicted c- phenotype, but rhce*diiia(1-2)-cevs.03 not interrogated by id core xt, is associated with partial c+ phenotype.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 limitations described in the id core xt package insert (limitations 1 and 9).

• Brand Name: ID CORE XT
• Common Device Name: 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: 17849775
• Report Number: 3006413195-2023-00018
• Device Sequence Number: 19696162
• Product Code: PEP
• UDI-Device Identifier: 08437013457019
• UDI-Public: (01)08437013457019(17)230517(10)0203000030
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2024
• Device Catalogue Number: 1021720000
• Device Lot Number: 0203000030
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 07/31/2024
• Date Device Manufactured: 02/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown