BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4210335 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44705
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE HAS RECEIVED SEVERAL NO DELIVERY ALARMS. CUSTOMER STATED THAT THE ALARMS USUALLY OCCUR DURING BOLUS DELIVERY AFTER MEALS AND HE HAS HAD MANY HIGH BLOOD GLUCOSE EVENTS DUE TO THIS. CUSTOMER CHANGED THE INFUSION SET EVERY THREE DAYS. CUSTOMER STATED HE HAS NOT NOTED ANY VISIBLE DAMAGE TO THE INFUSION SET OR RESERVOIR OR ANY OCCLUSION. CUSTOMER WAS ADVISED ON FREQUENTLY CHANGING THE INFUSION SET AND RESERVOIR AND ROTATING THE INSERTION SITE. CUSTOMER ALSO COMPLAINED ABOUT THE SENSOR LASTING LESS THAN 6 DAYS. CUSTOMER STATED HE HAS RECEIVED CALIBRATION ERRORS, CHANGE SENSOR AND SENSOR END ALERTS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694160 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR