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

Model Number 1020220034

Device Problem False Positive Result (1227)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols ih center for bi-directional sequencing.Sequencing interrogated jk gene exons 3 to 10 and the genotype jk*a(191a) homozygous was identified.The allele jk*b(191a) is a null allele reported by isbt, jk*02n.09, but this null mutation is not reported on a jk*a background.Since the genotype result is jk*a(191a) homozygous and the serology is jka-, the new null allele jk*a(191a) is confirmed.Id core xt reported a predicted jka+ phenotype, but jk*a (191a) null allele, not interrogated by id core xt, is found associated with a jka- phenotype.This false positive result obtained by id core xt is considered a discrepant result ,and then a malfunction.This limitation is covered by the general assay limitations described in the id core xt package insert (limitations 1 and 10).

Event Description

The customer reported a possible discrepancy.The serological phenotype was jka- and the id core xt genotype suggested a phenotype of jka+.

• 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: 10577288
• MDR Text Key: 208833085
• Report Number: 3006413195-2020-00018
• Device Sequence Number: 1
• Product Code: PEP
• Combination Product (y/n): N
• Reporter Country Code: KU
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2020

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: 05/07/2020
• Device Model Number: 1020220034
• Device Lot Number: 0203000018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2019
• 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