BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3801110 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-84521
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 STATED THAT SHE IS EXPERIENCING HIGH BLOOD GLUCOSE. CUSTOMER HAS INCREASED THE BASAL AND SHE IS STILL RUNNING HIGH. THE CURRENT BLOOD GLUCOSE READING IS 387 MG/DL. CUSTOMER TREATED WITH A BOLUS AND MANUAL INJECTION. THE DRIVE SUPPORT CAP FLUSH. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277692 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR