BEUDAMED
    FDA Adverse Event Summary report: N

    530G INSULIN PUMP

    MDR report key: 3930602 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86835
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 REPORTED HIGH BLOOD GLUCOSE LEVELS WHILE WEARING THE INSULIN PUMP. SHE STATED THAT SHE GOT THE NEW INSULIN PUMP WITH THE SENSOR AND WHILE SHE WAS BEING TRAINED ON IT, HER BLOOD GLUCOSE LEVELS KEPT RISING. THE SENSOR IS WORKING. SHE THINKS THE DEVICE IS PROGRAMMED CORRECTLY. HER BLOOD GLUCOSE LEVEL HAS BEEN AROUND 300 MG/DL SINCE EARLIER TODAY. WHEN SHE GOT STUCK ON THE FREEWAY, IT DROPPED DOWN TO 51 MG/DL. CUSTOMER'S BLOOD GLUCOSE IS CURRENTLY 348 MG/DL. SHE SAID SHE FELT HER CHEST WAS TIGHT. CUSTOMER TREATED WITH A SHOT. DURING TROUBLE SHOOTING, THE DRIVE SUPPORT CAP APPEARED NORMAL. INSULIN EXITED THE TUBING DURING MANUAL PRIME. A LEAK WAS NOT FOUND. CUSTOMER WAS ADVISED THAT THE DEVICE IS WORKING AS DESIGNED. SHE WAS ADVISED ON PROPER INFUSION SET CHANGES AND TOLD TO MONITOR HER BLOOD GLUCOSE LEVELS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408818 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR