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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 Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2021
Event Type  malfunction  
Event Description
The customer reported a malfunction of id core xt.Serology phenotype: k (upper case) (b)(6), k (b)(6); id core xt phenotipe: k (upper case) (b)(6).
 
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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 Key12878198
MDR Text Key281279680
Report Number3006413195-2021-00015
Device Sequence Number1
Product Code PEP
UDI-Device Identifier08437013457019
UDI-Public(01)08437013457019(17)220205(10)0203000023
Combination Product (y/n)N
Reporter Country CodeIT
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 11/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2021
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 Numberv3
Device Catalogue Number1020220034
Device Lot Number0203000023
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/10/2020
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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