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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROGENIKA BIOPHARMA S.A. ID CORE XT
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PROGENIKA BIOPHARMA S.A. ID CORE XT Back to Search Results
Model Number 1020220034
Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation is on-going.
 
Event Description
The customer reported a possible discrepancy.The serological phenotype was fy(a-, b+) and the id core xt genotype suggested a phenotype of fy(a+, b+).
 
Manufacturer Narrative
The genomic dna sample was sent to grifols ih center for next generation sequencing.Sequencing interrogated fy proximal promoter, exons 1-2 and the variant fy:c.407g>a was identified.This unreported variant was associated by cloning and sequencing to fy*a allele (fy*a(407a) allele).Id core xt reported a predicted fya+ positive phenotype, but fy:c.407g>a variant, not interrogated by id core xt, is associated with fya- phenotype based on the serology result.This false positive result obtained by id core xt are 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).
 
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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
MDR Report Key10359819
MDR Text Key203888733
Report Number3006413195-2020-00012
Device Sequence Number1
Product Code PEP
Combination Product (y/n)N
PMA/PMN Number
BP170154
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date05/07/2020
Device Model Number1020220034
Device Lot Number0203000018
Was Device Available for Evaluation? No
Date Manufacturer Received07/02/2020
Is This a Reprocessed and Reused Single-Use Device? Yes
Removal/Correction NumberN/A
Patient Sequence Number1
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