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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROGENIKA BIOPHARMA, S.A ID CORE XT; ANTIGEN GENOTYPING TEST
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PROGENIKA BIOPHARMA, S.A ID CORE XT; ANTIGEN GENOTYPING TEST Back to Search Results
Model Number V3
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2022
Event Type  malfunction  
Event Description
The test result was negative (k minor-) with serology, which was in contrast to molecular typing of the same sample performed on (b)(6) 2022, using the id core xt assay which provided positive results (k minor+).
 
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Brand Name
ID CORE XT
Type of Device
ANTIGEN GENOTYPING TEST
Manufacturer (Section D)
PROGENIKA BIOPHARMA, S.A
ibaizabal bidea, edificio 504
parque tecnol?gico de bizkaia
derio, bizkaia 48160
SP  48160
Manufacturer (Section G)
PROGENIKA BIOPHARMA, S.A
ibaizabal bidea, edificio 504
parque tecnol?gico de bizkaia
derio, bizkaia 48160
SP   48160
Manufacturer Contact
jokin del amo
ibaizabal bidea, edificio 504
parque tecnol?gico de bizkaia
derio, bizkaia 48160
SP   48160
MDR Report Key16073298
MDR Text Key308373849
Report Number3006413195-2022-00009
Device Sequence Number1
Product Code PEP
UDI-Device Identifier08437013457019
UDI-Public(01)08437013457019(17)230223(10)0203000026
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 Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/23/2023
Device Model NumberV3
Device Catalogue Number1021720000
Device Lot Number0203000026
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/23/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/25/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
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