MAUDE Adverse Event Report: PROGENIKA BIOPHARMA, S.A ID CORE XT; ANTIGEN GENOTYPING TEST

Model Number	v3
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See section b6.
Event or Problem Description
It was reported that the sample (b)(6).From "memorial blood center", was tested with serology.The test result was positive (c+), which contrasted with the molecular typing performed on (b)(6) 2023, using the id core xt assay which provided negative results (c-), with id core xt analysis software v3.0.4.1.The lot of id core xt used was lot 0203000028.

• Brand Name: ID CORE XT
• Common Device Name: ANTIGEN GENOTYPING TEST
• Manufacturer (Section D): PROGENIKA BIOPHARMA, S.A; ibaizabal bidea, edificio 504; parque tecnologico de bizkaia; derio, bizkaia 48160 ; SP 48160
• Manufacturer Contact: jokin amo ; ibaizabal bidea, edificio 504; parque tecnologico de bizkaia; derio, bizkaia 48160 ; SP 48160
• MDR Report Key: 17096909
• Report Number: 3006413195-2023-00012
• Device Sequence Number: 7690690
• Product Code: PEP
• UDI-Device Identifier: 08437013457019
• UDI-Public: (01)08437013457019(17)231026(10)0203000028
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/26/2023
• Device Model Number: v3
• Device Catalogue Number: 1021720000
• Device Lot Number: 0203000028
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown