BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4141175 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-32761
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFOR,E CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN HE HAS BEEN RECEIVING WEAK SIGNAL ALERTS. CUSTOMER STATED HE WEARS THE TRANSMITTER AND THE INSULIN PUMP ON OPPOSITE SIDES OF HIS BODY AND HE WORKS IN AN EMERGENCY ROOM. CUSTOMER STATED THAT HE IS AROUND WIRELESS EQUIPMENT ALL THE TIME, CUSTOMER WAS ADVISED TO TRY AND STEP AWAY FROM THE AREA WHEN ISSUE OCCURS TO REGAIN SIGNAL. BLOOD GLUCOSE VALUE IS 220 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618584 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS A2751NASJ

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR