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

Model Number 1020220034

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

The genomic dna sample was sent to grifols ih center for bi-directional sanger sequencing.Sequencing interrogated co gene exons 1 to 4.The obtained genotype is a mix of major allele co*b (86-87%) and minor allele co*a (13-14%).In a regular genotype co*a, co*b, both alleles are represented 50% each.Id core xt reported a genotype co*b, co*b but the low presence of co*a allele made id core xt failing in the detection of allele co*a and serology showing an ambiguous result.This false negative result obtained by id core xt is considered a discrepant result and then a malfunction.This sample corresponds to a multi-transfused patient with acute myeloblastic leukaemia (aml).An investigation is still running to determine if the clinical and/or transfusion history of the patient is the cause of the malfunction.

Event Description

Discrepancy in results.Id core xt result rare genotype / phenotype: colton (a-b +).Another genotyping method is co (a + b +); serology is ambiguous.

Manufacturer Narrative

The genomic dna sample was sent to grifols ih center for bi-directional sanger sequencing.Sequencing interrogated co gene exons 1 to 4.The obtained genotype is a mix of major allele co*b (86-87%) and minor allele co*a (13-14%).In a regular genotype co*a, co*b, both alleles are represented 50% each.Id core xt reported a genotype co*b, co*b but the low presence of co*a allele made id core xt failing in the detection of allele co*a and serology showing an ambiguous result.This sample corresponds to a multi-transfused patient with acute myeloblastic leukaemia (aml).To find out the genotype of this sample for colton, dna extracted from saliva sample was sequenced and the obtained genotype was co*a, co*b.Hence, the concluded phenotype for this sample is coa+, cob+.This result confirmed that the blood sample from this patient is composed by white cells carrying unbalanced chromosome aberrations caused by the acute disease that lead to incorrect genotype by id core xt.This false negative 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 for false negative results.The possibility of including this limitation in the package insert in a more specific way will be evaluated with the corresponding health authorities.

• 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
• MDR Report Key: 10126185
• MDR Text Key: 208350907
• Report Number: 3006413195-2020-00007
• Device Sequence Number: 1
• Product Code: PEP
• Combination Product (y/n): N
• PMA/PMN Number: BP170154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1