BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4122397 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24837
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE HAD RECEIVED NO DELIVERY ALARM ON THE INSULIN PUMP. THE CUSTOMER STATED THAT HE TREATED THE HIGH BLOOD GLUCOSE HE EXPERIENCED AT THE TIME WITH A MANUAL INJECTION. HE ALSO STATED THAT THERE WAS BLOOD AT THE INSERTION SITE OF THE INSULIN SET HE WAS USING WHEN HE RECEIVED THE NO DELIVERY ALARM. AT THE TIME OF THE REPORTING, A BLOOD GLUCOSE OF 370 MG/DL WAS DOCUMENTED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579412 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR