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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 Problem False Positive Result (1227)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2019
Event Type  malfunction  
Manufacturer Narrative
The genomic dna sample was sent to (b)(4) for sequencing.Next generation sequencing interrogated rh gene exons 1 to 10 and the allele genotype rhce*ce, rhce*ce(281c,282t) was identified.Rhce*ce(281c,282t) variant allele is unreported.Therefore, the predicted phenotype for antigens c and e is unknown.However, the customer's c-,e- serology indicates that the single amino acid change associated with those two variants (leu94pro) alters the expression of c and e antigens.Id core xt reported a predicted c+, e+ phenotype, but null rhce*ce(281c,282t) variant allele, not interrogated by id core xt, is associated with c-, e- negative phenotype.The false positive results obtained by id core xt are considered a discrepant result and then a malfunction.This case report is covered by limitations number 1 and 8 of id core xt package insert.
 
Event Description
The customer reported a possible discrepancy.The sample is c+,e+ using id core xt assay but serology reported c-,e-.
 
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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 tecnologico de bizkaia
derio, 48160
SP  48160
Manufacturer (Section G)
PROGENIKA BIOPHARMA S.A.
ibaizabal bidea, edificio 504
parque tecnologico de bizkaia
derio, 48160
SP   48160
Manufacturer Contact
diego tejedor
ibaizabal bidea, edificio 504
parque tecnologico de bizkaia
derio, vizcaya 48160
SP   48160
MDR Report Key9438679
MDR Text Key191896569
Report Number3006413195-2019-00011
Device Sequence Number1
Product Code PEP
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
BP170154
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/09/2019
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 Date01/31/2020
Device Model Number1020220034
Device Lot Number0203000016
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/26/2019
Initial Date FDA Received12/09/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/10/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Removal/Correction NumberN/A
Patient Sequence Number1
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