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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 False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2022
Event Type  malfunction  
Event Description
The customer reported a malfunction of id core xt.Serology phenotype c positive; id core xt phenotipe: c negative.
 
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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
diego tejedor
ibaizabal bidea, edificio 504
parque tecnol?gico de bizkaia
derio, bizkaia 48160
SP   48160
MDR Report Key13625530
MDR Text Key291808589
Report Number3006413195-2022-00001
Device Sequence Number1
Product Code PEP
UDI-Device Identifier08437013457019
UDI-Public(01)08437013457019(17)220622(10)0203000024
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
Report Date 02/28/2022
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 Date06/22/2022
Device Model Numberv3
Device Catalogue Number1021720000
Device Lot Number0203000024
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2022
Initial Date FDA Received02/28/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/25/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
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