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 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to (b)(4) for sequencing.Next generation sequencing interrogated rh gene exons 1 to 10 and the following allele genotype was identified rhce*ce(ivs2+3133g),rhce*ce.The presence of unpublished variant rhce*c.Ivs2+3133a>g prevents binding of one of the id core xt rhce intron 2 probes which detect c antigen (rhce*c-specific109-bp insert) and consequently the prediction of c positive antigen.Id core xt reported a predicted c- phenotype, due to the presence of rhce*c.Ivs2+3133a>g variant which causes an allele drop-out, being the correct predicted phenotype c positive.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 c- using id core xt assay but serology reported c+.

• 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: 9438719
• MDR Text Key: 191896538
• Report Number: 3006413195-2019-00010
• Device Sequence Number: 1
• Product Code: PEP
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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
• 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: 0203000014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2019
• 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