BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4182605 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39860
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE READINGS OF 630 MG/DL AND DIABETES KETOACIDOSIS. CUSTOMER REPORTED SYMPTOMS OF NAUSEA, VOMITING, URINATION AND IRRITABILITY PRIOR TO THE HOSPITALIZATION. CUSTOMER WAS TREATED WITH MANUAL INJECTIONS AT THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP AND ALL SETTINGS APPEARED TO BE NORMAL. HIGH PRESSURE TEST WAS PERFORMED AND PASSED. THE CANNULA WAS NOTED TO BE BENT. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 321 MG/DL AND WAS TREATED WITH A BOLUS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660941 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization