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 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols laboratory solution for dna sequencing.Dna sequencing interrogated specific sequences: kel gene exons 1-9.The kel genotype detected two kel*k alleles in agreement with id core xt but also a homozygous mutation c.1546c>t reported as ko allele kel*02n.17.This mutation is associated with a null ko phenotype which explains the serology discrepancy.Id core xt reported a predicted k+ phenotype, but kel*02n.17 allele is associated with a predicted k- phenotype.This 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 Description

It was reported that the sample 8074933, from madrid blood transfusion center, was tested with serology.The test result was negative (k-), which contrasted with the molecular typing performed on (b)(6) 2023, using the id core xt assay which provided positive results (k+) 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: 17893663
• MDR Text Key: 325352593
• Report Number: 3006413195-2023-00020
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 08437013457064
• UDI-Public: (01)08437013457064(17)240207(10)0203000029
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2024
• Device Catalogue Number: 1020220034
• Device Lot Number: 0203000029
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• 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