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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
Catalog Number 1021720000
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2023
Event Type  malfunction  
Event Description
The customer reported a malfunction.Id core xt phenotype result was c-(major c) and serological result was c+.
 
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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 Key16565788
MDR Text Key311710558
Report Number3006413195-2023-00010
Device Sequence Number1
Product Code PEP
UDI-Device Identifier08437013457064
UDI-Public(01)08437013457064(17)230602(10)0203000027
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 Physician
Type of Report Initial
Report Date 03/17/2023
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 Date06/02/2023
Device Catalogue Number1021720000
Device Lot Number0203000027
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/22/2023
Initial Date FDA Received03/17/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/07/2022
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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