BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAP

    MDR report key: 4110550 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27389
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK
    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 EXPERIENCING HIGH BLOOD GLUCOSE OF 496 MG/DL; TREATED WITH INSULIN PUMP. CUSTOMER COMPLAINED ABOUT HAVING TWO SENSORS GET STUCK IN THE SERTER AND ALSO THAT WHEN SHE INSERTED SENSOR THE CANNULA WAS BENT. LAST BLOOD GLUCOSE VALUE IS 245 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591389 530G INSULIN PUMP MMT-751NAP OZO OZO MEDTRONIC MINIMED MMT-751NAP A3751NAPJ

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR