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

Model Number 1020220034

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/28/2021

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 s (upper case) negative,s positive but when tested with id core xt resulted phenotype was s (upper case) positive,s positive.

Manufacturer Narrative

B6: the genomic dna sample was sent to grifols ih center for dna sequencing of gypb exons 1-2, 4-6 and pseudo-exon 3.Two variants were found: gypb: c.251g>c when alone has only been described on the gypb*s allele (vox sang.2017 jun;112 suppl 1:55) and doesn't affect the expression of the s antigen and gypb: c.271-2a>t in intron 5 that has not been previously reported.Although its effect is unknown, the most probable location of this variant is on the allele gypb*s, based on the serology results, s (upper case) negative.Id core xt reported a predicted s (upper case) positive phenotype, but the serology data from the user is s-, due to the not interrogated variant gypb: c.271-2a>t.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 limitation described in the id core xt package insert (limitation 1 and 10).

• 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: 12516361
• MDR Text Key: 272904907
• Report Number: 3006413195-2021-00011
• Device Sequence Number: 1
• Product Code: PEP
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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

• Date FDA Received: 09/22/2021
• 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: 1020220034
• Device Lot Number: 0203000023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2021
• 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