BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4191124 · Received October 21, 2014

    Report

    Report Number
    3004209178-2014-98368
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    May 2, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    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 REPORTED NO DELIVERY ALARMS OCCURRING DURING A BOLUS. CUSTOMER STATED THAT HE HAD TO CALCULATE THE REMAINING BOLUS TO DELIVER AND THEN RE-ENTER THE AMOUNT TO DELIVER. HE STATED THAT THE CANNULA WAS NOT EVER BENT. HE REPORTED THAT HE HAD NOT HAD ANY RAMPING OF NUMBERS, BUTTON ERRORS OR UNRESPONSIVE BUTTONS. HE ALSO REPORTED THAT DURING A SET CHANGE A DROP OF BLOOD HAD GONE INTO THE TUBING. CUSTOMER DID NOT HAVE A SPECIFIC BLOOD GLUCOSE READING TO GIVE. HE WAS UNABLE TO TROUBLESHOOT FOR NO DELIVERY AS IT HAD BEEN A PAST EVENT AND WAS ALREADY RESOLVED. CUSTOMER WAS ADVISED ON PROTOCOL FOR INSERTION AND PRIMING OF THE TUBING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670366 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR