BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3941755 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87472
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING NO DELIVERY. CUSTOMER STATES THAT THEY RECEIVED THE ALARM DURING BOLUS DELIVERY AND WAS ABLE TO TROUBLESHOOT THE DEVICE THEMSELVES. CUSTOMER BELIEVES THE ISSUE WAS A KINK IN THE INFUSION SET TUBING. BLOOD GLUCOSE LEVEL WAS 213 MG/DL AT TIME OF REPORTING. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LEAD TO THE ALARM OR IF THE DEVICE WAS DROPPED. ASSISTED CUSTOMER WITH ENTERING CORRECT BOLUS AMOUNT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419713 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR