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

Model Number 1020220034

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols ih center for sequencing.Next generation sequencing interrogated rh genes proximal promoter, exons 1-10, and portions of intron 2-3.No variant was found in rh genes and sequencing provided a genotype rhce*ce, rhce*ce, but id core xt reported a genotype rhce*ce, rhce*ce.Id core xt determines c/c antigens interrogating polymorphism rhce:c.335+3039ins109 in rhce gene intron 2.The presence of the 109 bp insert is associated with c antigen.However, this sample carries a rare allele described by isbt as rhce*02.37 that provides a c+ phenotype but lacks the 109 bp insert.Id core xt reported a predicted c- phenotype, but the serology data from the user is c+, due to the presence of rare rhce*02.37 allele.Since id core xt obtained a false negative result, this is considered a discrepant result and then a malfunction.This limitation is covered by the general assay limitation described in the id core xt package insert (limitation 1).

Event Description

The customer reported a possible discrepancy.The serological phenotype was c+, c+ and the id core xt c-, c+.

• 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: 10378263
• MDR Text Key: 219199896
• Report Number: 3006413195-2020-00013
• 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: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2020
• Device Model Number: 1020220034
• Device Lot Number: 0203000020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1