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 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to (b)(6) center for bi-directional sequencing and next generation sequencing.Sequencing interrogated rh gene exons 1 to 10.An unpublished triplicated rhce*ce allele which involves intron 4 and exon 5 sequence of rhce gene, where primers and probes of id core xt assay for antigen e detection are located, is present in this sample.The heterozygous presence of this rare allele would explain the serology of this sample and the imbalanced amplification of id core xt giving an incorrect predicted allele genotype rhce*ce, rhce*ce and an incorrect predicted e- phenotype.Id core xt reported a predicted e- phenotype due to the presence of an unpublished triplicated rhce*ce allele which causes an imbalanced amplification of id core xt primers for antigen e detection.This false negative result obtained by id core xt is considered a discrepant result and then a malfunction.This case report is associated with a new limitation of id core xt assay.

Event Description

The customer reported a possible discrepancy.The sample is e- using id core xt assay but serology reported e+.

• 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: 9438643
• MDR Text Key: 191019487
• Report Number: 3006413195-2019-00004
• 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: 01/31/2019
• 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