Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROGENIKA BIOPHARMA, S.A ID CORE XT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PROGENIKA BIOPHARMA, S.A ID CORE XT Back to Search Results
Model Number 1021920000
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2020
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 s-s- and the id core xt genotype suggested a phenotype of s-s+.
 
Manufacturer Narrative
Additional information: - conclusion of the mdr: no investigation can be performed.The customer cannot send the sample to progenika biopharma, s.A.For more investigation, so the complaint has been closed.-a1.Patient identifier, - g6.Type of report, -h2.If follow-up, what type, - h6.Adverse event problem: investigation findings and investigation conclusion, - h10 additional narrative/data.Corrected data: -b3.Date of event, -h6.Adverse event problem, - h6.Adverse event problem: type of investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11448549
MDR Text Key245135055
Report Number3006413195-2021-00002
Device Sequence Number1
Product Code PEP
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 06/14/2021
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 Date10/01/2020
Device Model Number1021920000
Device Lot Number0203000020
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/05/2021
Initial Date FDA Received03/09/2021
Supplement Dates Manufacturer Received02/05/2021
Supplement Dates FDA Received06/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-