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	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The genomic dna sample was sent to grifols laboratory solution for dna sequencing of gypa exons 1 to 7.The variant c.38-66a>g in heterozygous was detected on exon 2 of the gene gypa, affecting the binding region of id core xt exon 2 forward primer.The id core xt predicted genotype for this sample was gypa*n homozygous with an associated predicted phenotype m-n+, but the dna sequencing detects the genotype gypa*m(c.38-66g), gypa*n with a predicted phenotype m+n+, consistent with serology result m+.This rare variant is not described in the literature and affects to the detection of the gypa*m allele by id core xt.Id core xt predicted genotype result for this sample was gypa*n, but according to the sequencing result and the m positive serology data, the predicted phenotype is m positive.This false negative result obtained by id core xt is considered a discrepant result and then a malfunction.This case report is associated with a specific limitation of id core xt assay described in the id core xt package insert (limitation 9.4).
Event or Problem Description
It was reported that the sample (b)(6) from "lifesouth community blood center", was tested with serology.The test result was positive (m+), which contrasted with two molecular typing performed on (b)(6) 2024 and (b)(6) 2024, using the id core xt assay which provided negative results (m-) with id core xt analysis software v3.0.5.12.

• 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: 19497700
• Report Number: 3006413195-2024-00010
• Device Sequence Number: 20498506
• Product Code: PEP
• UDI-Device Identifier: 08437013457019
• UDI-Public: (01)08437013457019(17)241226(10)0203000032
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: 12/26/2024
• Device Catalogue Number: 1021720000
• Device Lot Number: 0203000032
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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