BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4780744 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-57450
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    March 30, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE FOR THE PAST TWO WEEKS. THE CUSTOMER REPORTED THEIR BLOOD GLUCOSE RANGED FROM 500 MG/DL TO 600 MG/DL. THE CUSTOMER STATED THEIR BLOOD GLUCOSE WAS 72 MG/DL EARLIER IN THE MORNING, BUT ROSE TO 453 MG/DL 30 MINUTES BEFORE THE CALL. THE CUSTOMER HAS BEEN TREATING THEIR BLOOD GLUCOSE WITH THE INSULIN PUMP. IT WAS ALSO FOUND THE CUSTOMER'S BLOOD GLUCOSE WOULD DECLINE WITH A SITE CHANGE. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 700 MG/DL. THE CUSTOMER ALSO REPORTED BEING ADMITTED INTO THE INTENSIVE CARE UNIT ON (B)(6) 2015 WITH A BLOOD GLUCOSE OF 700 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324694 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization