BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIO CENTRIFUGE MODULE

    MDR report key: 3131866 · Received May 29, 2013

    Report

    Report Number
    2432235-2013-00193
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SERVICE CONSULTANT (TSC) WAS CONTACTED BY THE CUSTOMER. THE TSC EVALUATED THE APTIO CENTRIFUGE MODULE DATA AND DETERMINED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR APTIO CENTRIFUGE MODULE STOPPED FUNCTIONING FOR 1.75 HOURS. THE CUSTOMER WAS PROCESSING 14 ACCIDENT AND EMERGENCY SAMPLES, THAT POTENTIALLY BREACHED THEIR SAMPLE PROCESSING TURN-AROUND TIME. THERE WERE NO DISCORDANT RESULTS PROVIDED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM CAUSED BY THE APTIO CENTRIFUGE NON-FUNCTIONING. THERE ARE NO REPORTS OF PATIENT ADVERSE HEALTH CONSEQUENCES DUE TO THE NON-FUNCTIONING APTIO CENTRIFUGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237148 APTIO CENTRIFUGE MODULE LABORATORY AUTOMATION SYSTEM, JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1