BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3880231 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-85664
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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'S MOTHER REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CALLER STATED THAT CUSTOMER HAS HAD PROBLEMS WITH HIS INSULIN PUMP AND SUPPLIES. THE INSULIN PUMP KEPT ALARMING NO DELIVERY. THE BLOOD GLUCOSE READINGS ARE NOT COMING DOWN. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 417 MG/DL. CUSTOMER WAS VOMITING, LARGE KETONES AND ABDOMINAL PAIN. CALLER FOUND MULTIPLE BENT CANNULAS. HOSPITAL TREATED WITH A COUPLE BAGS OF FLUID. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357709 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization