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

Model Number 1021720000

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols ih center for next-generation sequencing of rh proximal promoter, exons 1-10 and portions of introns 2-3.The variant rhce:c.335+3133a>g was identified on allele rhce*ce.The failure of id core xt to detect the 109-bp intron 2 associated with the rhce*c allele is due to the presence of rhce:c.335+3133a>g variant at the probe site.Id core xt reported a predicted c- phenotype, but rhce:c.335+3133a>g variant is associated with an allele drop-out.This false negative result obtained by id core xt is considered a discrepant result and then a malfunction.This case report is associated with limitation 9 of id core xt assay described in the id core xt package insert.

Event Description

The customer reported a possible discrepancy.The serological phenotype was c+ but when tested with id core xt resulted phenotype was c- (rhce*ce).

• 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: 12340248
• MDR Text Key: 267921095
• Report Number: 3006413195-2021-00006
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 08437013457019
• UDI-Public: (01)08437013457019(17)211217(10)0203000022
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2021
• Device Model Number: 1021720000
• Device Catalogue Number: 1021720000
• Device Lot Number: 0203000022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1