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 01/12/2024

Event Type  malfunction  

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 (jka-), which contrasted with the molecular typing performed on (b)(6) 2024, using the id core xt assay which provided positive results (jka+), with id core xt analysis software v3.0.2.

Manufacturer Narrative

The genomic dna sample was sent to grifols laboratory solution for dna sequencing ofjk proximal promotor and exons 1-10.The genotype jk*01n.18(588g), jk*02w.03 was identified with a predicted phenotype jka-, jkb+weak.The reported serology is jka-, in agreement with sequencing and discrepant with id core xt which reported jka+.The variant c.190c>t is described by isbt as the null allele jk*01n.18 which is associated with jka negative expression.Id core xt reported a predicted jka+ phenotype, but jk*01n.18(588g) null allele is associated with a predicted jka- 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).

• 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: 18694281
• MDR Text Key: 336426868
• Report Number: 3006413195-2024-00003
• Device Sequence Number: 1
• Product Code: PEP
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• 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: 0203000032
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• 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