MAUDE Adverse Event Report: PROGENIKA BIOPHARMA S.A. ID CORE XT

Model Number 1020220034

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to (b)(4) for bi-directional sequencing.Sequencing interrogated jk gene exons 3 to 10 and the following allele genotype was identified jk*a(130a, 190t),jk*b(130a).Jk*a(130a) variant allele is a weak allele reported by isbt as jk*01w.01.Placement on jk*a or jk*b allele of variant jk*c.190t is unknown (2015 vox sanguinis vol.109 suppl.1 p.286 p-584).Jk*b(130a) variant allele has not been previously reported.The serology result of this sample jka-,jkb+ suggest that jk*a(130a, 190t) variant allele affect to the expression of jka antigen.Id core xt reported a predicted jka+ phenotype, but jk*a(130a,190t) variant allele, not interrogated by id core xt, is associated with jka negative phenotype.The false positive result obtained by id core xt is considered a discrepant result and then a malfunction.This case report is covered by limitations number 1 and 10 of id core xt package insert.

Event Description

The customer reported a possible discrepancy.The sample is jka+,jkb+ using id core xt assay but serology reported jka-,jkb+.

• Brand Name: ID CORE XT
• Type of Device: ID CORE XT
• Manufacturer (Section D): PROGENIKA BIOPHARMA S.A.; ibaizabal bidea, edificio 504; parque tecnologico de bizkaia; derio, 48160 ; SP 48160
• Manufacturer (Section G): PROGENIKA BIOPHARMA S.A.; ibaizabal bidea, edificio 504; parque tecnologico de bizkaia; derio, 48160 ; SP 48160
• Manufacturer Contact: diego tejedor ; ibaizabal bidea, edificio 504; parque tecnologico de bizkaia; derio, vizcaya 48160 ; SP 48160
• MDR Report Key: 9438729
• MDR Text Key: 191896575
• Report Number: 3006413195-2019-00012
• Device Sequence Number: 1
• Product Code: PEP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: BP170154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2020
• Device Model Number: 1020220034
• Device Lot Number: 0203000018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1