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

Catalog Number 1020220034

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2022

Event Type  malfunction  

Event Description

Customer reported a malfunction of id core xt.The serological phenotype result was c(major)c(minor), when the sample is tested with id core xt, the result was cc (minor both).

Manufacturer Narrative

It is attached, fda requests additional information letter and mail received in progenika on march 07, 2023, and the answer to that letter sent by progenika to fda by email on march 16, 2023.

• 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 Key: 16352410
• MDR Text Key: 309504939
• Report Number: 3006413195-2023-00004
• Device Sequence Number: 1
• Product Code: PEP
• UDI-Device Identifier: 08437013457064
• UDI-Public: (01)08437013457064(17)230602(10)0203000027
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: BP170154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2023
• Device Catalogue Number: 1020220034
• Device Lot Number: 0203000027
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1