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 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols ih center for bi-directional sequencing.Sequencing interrogated klf1 gene exons 1 to 3 and dna cloning plus new sequencing of interrogated klf1 exon 2.One allele was identified as klf1*304c,544c and the other allele was identified as klf1*948delc.Although the klf1*304c allele variant is described by isbt as klf1*bgm12, the klf1*304c,544c variant alllele is unreported and its effect on lutheran antigen expression is unknown.Klf1*948delc, the other variant allele found in this sample, has been reported by isbt as klf1*bgm18 and associated with an in(lu) phenotype.However, the lu*b allele detected in homozygosity by idcore xt and the lub- phenotype detected by serology suggest that klf1*304c,544c variant allele leads also to an in(lu) phenotype.Id core xt reported a predicted lub+ phenotype, but the presence of klf1*304c,544c, klf1*948delc allele genotype, not interrogated by id core xt, avoid the expression of lub antigen.This 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 lub+ using id core xt assay but serology reported lub-.

• 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: 9438658
• MDR Text Key: 191896432
• Report Number: 3006413195-2019-00006
• 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: 06/14/2019
• Device Model Number: 1020220034
• Device Lot Number: 0203000013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2018
• 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