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 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to (b)(4) for bi-directional sequencing.Sequencing interrogated kel gene exons 1 to 19 and the homozygous allele genotype kel*k(1216t) was identified.This variant allele was reported by isbt as kel*02n.15 which encodes a null kell phenotype, k0.This kell phenotype is k-, k-, kpa-, kpb-, jsa-, jsb-.Id core xt reported a predicted k+, kpb+ phenotype, but null kel*k(1216t) variant allele, not interrogated by id core xt, is associated with k-, kpb- negative phenotype.The false positive results obtained by id core xt are 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 k+, kpb+ using id core xt assay but serology reported k-, kpb-.

• 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: 9438723
• MDR Text Key: 191896498
• Report Number: 3006413195-2019-00009
• Device Sequence Number: 1
• Product Code: PEP
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: BP170154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• 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: 07/03/2019
• Device Model Number: 1020220034
• Device Lot Number: 0203000014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2018
• 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