MAUDE Adverse Event Report: PROGENIKA BIOPHARMA, S.A ID CORE XT; ANTIGEN GENOTYPING TEST

Catalog Number 1020220034

Device Problem False Positive Result (1227)

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

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols laboratory solutions for dna sequencing of gypb exons 1-2, 4-6 and pseudoexon 3.One variant was found: c.271-2a>t which has been described previously.Id core xt predicted genotype is gypb*s, gypb*s with a predicted phenotype s+s+ which is discrepant with the s-s+ serology data.These results suggest that the sequencing genotype result, gypb*s(271-2a>t), gypb*s is associated with a predicted phenotype s-s+.This false positive result obtained by id core xt is considered a discrepant result and then a malfunction.This case report is associated with limitations of id core xt assay, as described in the id core xt package insert (limitation 1 and 10).

Event Description

It was reported that the sample e004822089424, from "centro vasco de transfusiones y tejidos humanos", was tested with serology.The test result was negative (s-), which contrasted with the molecular typing performed on (b)(6) 2022, using the id core xt assay which provided positive results (s+), with id core xt analysis software v3.0.2.

Manufacturer Narrative

The genomic dna sample was sent to grifols laboratory solutions for dna sequencing of gypb exons 1-2, 4-6 and pseudoexon 3.One variant was found: c.271-2a>t which has been described previously.Id core xt predicted genotype is gypb*s, gypb*s with a predicted phenotype s+s+ which is discrepant with the s-s+ serology data.These results suggest that the sequencing genotype result, gypb*s(271-2a>t), gypb*s is associated with a predicted phenotype s-s+.This false positive result obtained by id core xt is considered a discrepant result and then a malfunction.This case report is associated with limitations of id core xt assay, as described in the id core xt package insert (limitation 1 and 10).

Event Description

It was reported that the sample (b)(6), from "centro vasco de transfusiones y tejidos humanos", was tested with serology.The test result was negative (s-), which contrasted with the molecular typing performed on (b)(6) 2022, using the id core xt assay which provided positive results (s+), with id core xt analysis software v3.0.2.

• Brand Name: ID CORE XT
• Type of Device: ANTIGEN GENOTYPING TEST
• Manufacturer (Section D): PROGENIKA BIOPHARMA, S.A; ibaizabal bidea, edificio 504; parque tecnologico de bizkaia; derio, bizkaia 48160 ; SP 48160
• Manufacturer Contact: jokin amo ; ibaizabal bidea, edificio 504; parque tecnologico de bizkaia; derio, bizkaia 48160 ; SP 48160
• MDR Report Key: 17142472
• MDR Text Key: 317308993
• Report Number: 3006413195-2023-00014
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 08437013457064
• UDI-Public: (01)08437013457064(17)230111(10)0203000025
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Catalogue Number: 1020220034
• Device Lot Number: 0203000025
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1