BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3945973 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-88039
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 16, 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
    CA
    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 THEIR SENSOR LASTED FOR LESS THAN SIX DAYS BEFORE HER RECEIVED A LOST SENSOR ALERT. HE STATED THAT THIS SENSOR HAS ALREADY BEEN REMOVED FROM HIS BODY. CUSTOMER STATED THAT HE HAS NOT RECEIVED A NEW TRANSMITTER AND THE CORRECT TRANSMITTER IDENTIFICATION IS PROGRAMMED INTO THE INSULIN PUMP. AFTER FULLY CHARGING THE TRANSMITTER, THE CUSTOMER STATED THAT THE INSULIN PUMP WAS COMMUNICATING WITH THE TRANSMITTER. CUSTOMER STATED THAT HE HAD PREVIOUSLY RECEIVED LOST SENSOR ALARMS AND TRIED TO CONNECT TO LOST SENSOR, BUT HIS ATTEMPTS FAILED. CUSTOMER BECAME FRUSTRATED AND THEN REMOVED THE SENSOR. BLOOD GLUCOSE VALUE 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
    425654 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR