BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR A3600

    MDR report key: 20986362 · Received December 20, 2024

    Report

    Report Number
    3010825766-2024-00005
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 25, 2024
    Report Date
    February 19, 2025
    Manufacturer
    INPECO SA
    Product Code
    JQP
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CODE ASSOCIATED TO K121012 HAS BEEN MODIFIED, FROM CEM TO JQP, AS PER FDA REQUEST. JQP IS MORE REPRESENTATIVE OF ACCELERATOR A3600, THE PRODUCT IMPACTED BY THE ISSUE.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INVESTIGATION FINDINGS, INPECO'S DEVICE, AND IN PARTICULAR THE ALIQUOTER MODULE, FUNCTIONS AS EXPECTED. THE ALIQUOTER MODULE IS SET CORRECTLY AND THERE ARE NO EVIDENCES OF PROBLEMS ON THE PIPETTOR ITSELF. MOREOVER, ACCORDING TO THE DETAILS PROVIDED BY THE CUSTOMER / DISTRIBUTOR, THE ELECTROLYTES PARAMETERS MEASURED ON THE ALIQUOTS ARE COMPARABLE; THEREFORE, THERE IS NO EVIDENCE OF DILUTION OF THE ALIQUOTS. NO ADDITIONAL ACTIONS BY INPECO ARE FORESEEN.

    Description of Event or Problem · 0

    TWO (2) ALIQUOTS FROM SAMPLE TUBE ID (B)(6) WERE TESTED FOR ESTRADIOL BY A THIRD-PARTY ANALYZER, CONNECTED TO INPECO LABORATORY AUTOMATION SYSTEM: THE RESULT OF ONE ALIQUOT WAS APPROXIMATELY 29; THE RESULT OF THE OTHER ALIQUOT WAS APPROXIMATELY 130. OTHER PARAMETERS (ELECTROLYTES, GLUCOSE) WERE MEASURED, AND THEY ARE THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164077 ACCELERATOR A3600 LABORATORY AUTOMATION SYSTEM JQP INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown