BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3945964 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-88037
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT HE HAS BEEN EXPERIENCING SOME LOST SENSOR ALERTS ABOUT TWICE PER WEEK DURING THE NIGHT. HE BELIEVES THESE ARE OCCURRING BECAUSE HE SLEEPS ON THE SENSOR. CUSTOMER STATED THAT HE BEGAN TAPING THE PUMP TO HIS BODY AT NIGHT BECAUSE THESE ALARMS WERE BECOMING MORE FREQUENT. CUSTOMER STATED THAT HIS CURRENT INSULIN PUMP AND SENSOR ARE IMPROVEMENTS COMPARED TO HIS PREVIOUS INSULIN PUMP. CUSTOMER ALSO STATED THAT ALTHOUGH HIS READINGS MAY BE A LITTLE OFF ONCE IN A WHILE, HE ENJOYS THE TRENDING ON THIS SENSOR AND IS ALWAYS ABLE TO GAUGE HIS SUGAR LEVELS. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425651 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR