BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID CORE XT

    MDR report key: 11448549 · Received March 9, 2021

    Report

    Report Number
    3006413195-2021-00002
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Date of Event
    June 18, 2020
    Report Date
    June 14, 2021
    Manufacturer
    PROGENIKA BIOPHARMA, S.A
    Product Code
    PEP
    PMA / PMN Number
    BP170154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ON-GOING. NO CONCLUSION IS AVAILABLE FOR THIS MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POSSIBLE DISCREPANCY. THE SEROLOGICAL PHENOTYPE WAS S-S- AND THE ID CORE XT GENOTYPE SUGGESTED A PHENOTYPE OF S-S+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340353 ID CORE XT ID CORE XT PEP PROGENIKA BIOPHARMA, S.A 1021920000 0203000020

    Patients

    Seq Age Sex Outcome Treatment
    1