BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4213497 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43389
    Event Type
    Malfunction
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OF 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

    SIT WAS REPORTED THAT THE CUSTOMER HAD A NO DELIVERY ALARM ON THE INSULIN PUMP WHY MANUALLY BOLUSING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 1053 MG/DL. CUSTOMER PERFORMED A 5.0U FIXED PRIME AND THE INSULIN EXITED THE TUBING. CUSTOMER WAS UNSURE IF CANNULA WAS BENT. CUSTOMER DECLINED TO REMOVE THE SET SINCE HE WILL STILL BE USING BASAL DELIVERY. IT WAS EXPLAINED THAT THERE MAY BE A POSSIBLE SITE RELATED ISSUE, POSSIBLY DUE TO A BENT CANNULA OR SITE/SET OCCLUSION. NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680638 530G INSULIN PUMP OZO MEDTRONIC PUERTO RICO OPERATIONS CO MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR