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

Model Number 1021720000

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.No conclusion is available for this malfunction.

Event Description

The customer reported a possible discrepancy.The serological phenotype was m+ (upper case) but when tested with id core xt resulted phenotype was m- (upper case).

Manufacturer Narrative

Corrected data: h3, h6.Additional data: b4, b6, g3, g6, h2, h10.B6: the genomic dna sample was sent to grifols ih center for dna sequencing of gypa exons 1 to 7.The variant gypa: c.136+58t in heterozygous was detected on intron 2 of the gene affecting the binding region of id core xt exon 2 reverse primer.The id core xt predicted genotype for this sample was gypa*n homozygous with an associated predicted phenotype m-n+ (upper case), but the dna sequencing detects the genotype gypa*m(c.136+58t), gypa*n with a predicted phenotype m+n+ (upper case), consistent with serology result m+ (upper case).This rare variant is not described in the literature and affects to the detection of the gypa*m allele by id core xt.Id core xt predicted genotype result for this sample was gypa*n, but according to the sequencing result and the m positive serology data , the predicted genotype is gypa*m(c.136+58t), gypa*n associated with a predicted phenotype m positive.This false m negative result obtained by id core xt is considered a discrepant result and then a malfunction.This case report is associated with limitation 9 of id core xt assay described in the id core xt package insert.

• 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: 12516380
• MDR Text Key: 272905191
• Report Number: 3006413195-2021-00008
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 08437013457019
• UDI-Public: (01)08437013457019(17)220205(10)0203000023
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP170154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

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: Health Professional
• Device Expiration Date: 02/05/2022
• Device Model Number: 1021720000
• Device Catalogue Number: 1021720000
• Device Lot Number: 0203000023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1