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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2021
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 e- but when tested with id core xt resulted phenotype was e+.
 
Manufacturer Narrative
The false positive result obtained by id core xt is not considered a discrepant result or malfunction.There is a deviation from the package insert instructions regarding sample quality.The customer is requested to extract and analyze a new sample that meets the quality requirements of the package insert.
 
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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 Key12096982
MDR Text Key259412794
Report Number3006413195-2021-00005
Device Sequence Number1
Product Code PEP
UDI-Device Identifier08437013457064
UDI-Public(01)08437013457064(17)220205(10)0203000023
Combination Product (y/n)N
PMA/PMN Number
BP170154
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/05/2022
Device Model Number1020220034
Device Lot Number0203000023
Was Device Available for Evaluation? No
Date Manufacturer Received06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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