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

Model Number 1020320010

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to (b)(6) center for bi-directional-sequencing.Sequencing interrogated rh genes exons 1 to 10.The rhce allele genotype: rhce*ce(48c,105t), rhd*cevs.03 and the rhd allele genotype: rhd*dau0, rhd*cevs.03 (4-7) were identified.The weak c antigen expression predicted on this patient's rbcs is encoded by the found rhd*cevs.03(4-7) variant allele, which is part of the r's type 2 haplotype.This c antigen was originally reported as very weak expression (2009 transfusion vol.49 p.495).Id core xt reported a predicted c- phenotype, but rhd*cevs.03(4-7) variant allele, which is part of the r's type 2 haplotype and not interrogated by id core xt, is associated with a very weak expression of c antigen.This false negative result obtained by id core xt is considered a discrepant result and then a malfunction.This case report is covered by limitation number 1 of id core xt package insert.

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: 9417785
• MDR Text Key: 190689678
• Report Number: 3006413195-2019-00001
• Device Sequence Number: 1
• Product Code: PEP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BP170154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2019
• Device Model Number: 1020320010
• Device Lot Number: 0203000014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2018
• 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