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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 1021720000
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2021
Event Type  malfunction  
Manufacturer Narrative
The genomic dna sample was sent to grifols ih center for next-generation sequencing of rh proximal promoter, exons 1-10 and portions of introns 2-3.The variant rhce:c.335+3133a>g was identified on allele rhce*ce.The failure of id core xt to detect the 109-bp intron 2 associated with the rhce*c allele is due to the presence of rhce:c.335+3133a>g variant at the probe site.Id core xt reported a predicted c- phenotype, but rhce:c.335+3133a>g variant is associated with an allele drop-out.This false 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.
 
Event Description
The customer reported a possible discrepancy.The serological phenotype was c+ but when tested with id core xt resulted phenotype was c- (rhce*ce).
 
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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
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 Key12340248
MDR Text Key267921095
Report Number3006413195-2021-00006
Device Sequence Number1
Product Code PEP
UDI-Device Identifier08437013457019
UDI-Public(01)08437013457019(17)211217(10)0203000022
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
BP170154
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/19/2021
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 Date12/17/2021
Device Model Number1021720000
Device Catalogue Number1021720000
Device Lot Number0203000022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/20/2021
Initial Date FDA Received08/18/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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