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

Model Number 1291720000

Device Problem False Positive Result (1227)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols ih center for sequencing.Next generation sequencing interrogated jk gene proximal promoter and exons 1-10 and the genotype jk*a(28a, 226a, 303a), jk*b was identified.Isbt describes variant jk*a: c.(28g>a) as jk*01w.03 associated to jka+w.Isbt describes variant jk*a: c.(226g>a) as jk*01w.04 associated to jka+w.Isbt describes variants jk*a: c.28g>a, jk*a: c.226g>a , jk*a: c.303g>a and jk*a: c.588a>g as allele jk*01n.20 associated to jka-.This last association although not complete is in concordance with serology result jka-.Id core xt reported a predicted jka+ phenotype, but serology test reported jka- result, due to the presence of variants jk*a: c.28g>a, jk*a: c.226g>a and jk*a: c.303g>a previously described as likely associated to jka-.This false positive result obtained by id core xt is considered a discrepant result and then a malfunction.This limitation is covered by the general assay limitations described in the id core xt package insert (limitations 1 and 10).

Event Description

The customer reported a possible discrepancy.The serological phenotype was jka negative and the id core xt genotype suggested a phenotype of jka positive.

• Brand Name: ID CORE XT
• Type of Device: ID CORE XT
• Manufacturer (Section D): PROGENIKA BIOPHARMA S.A.; ibaizabal bidea, edificio 504; parque tecnológico de bizkaia; derio, bizkaia 48160 ; SP 48160
• Manufacturer (Section G): PROGENIKA BIOPHARMA S.A.; ibaizabal bidea, edificio 504; parque tecnológico de bizkaia; derio, bizkaia 48160 ; SP 48160
• Manufacturer Contact: diego tejedor ; ibaizabal bidea, edificio 504; parque tecnológico de bizkaia; derio, bizkaia 48160 ; SP 48160
• MDR Report Key: 10230738
• MDR Text Key: 219199627
• Report Number: 3006413195-2020-00008
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 08437013457019
• UDI-Public: (01)08437013457019(17)081020(10)0203000019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP170154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/10/2020
• Device Model Number: 1291720000
• Device Catalogue Number: 1021720000
• Device Lot Number: 0203000019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2019
• 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