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

Catalog Number	1021720000
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The genomic dna sample was sent to grifols laboratory solutions for dna sequencing (ngs).The ngs sequencing interrogated kel promoter and exons 1-19, identifying the variant kel* c.2107 g>c in heterozygosis.The inferred genotype of sequencing is kel*01m.06(1680a), kel*k (kel*02) as described by isbt, and its predicted kmod phenotype would be associated with no expression of kell antigens.Id core xt reported a predicted k+ phenotype, but kel* c.2107 g>c variant, not interrogated by id core xt, is associated with k- phenotype.The false positive 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, as described in the id core xt package insert (sec 1 and 10 assay limitations).
Event or Problem Description
It was reported that the sample w051523064512, from memorial blood center, was tested with serology providing a negative result (k-), which contrasted with the molecular typing performed on 30nov23 using the id core xt assay which provided positive results (k+) with id core xt analysis software v3.0.4.1.

• 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: 18413957
• Report Number: 3006413195-2023-00022
• Device Sequence Number: 2748430
• Product Code: PEP
• UDI-Device Identifier: 08437013457019
• UDI-Public: (01)08437013457019(17)240517(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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2023

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: 12/01/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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