BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3870755 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-85610
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    March 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT THE INSULIN PUMP OVER-DELIVERED INSULIN. CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 20 MG/DL. CUSTOMER STATED THAT HIS WIFE CALLED THE PARAMEDICS. CUSTOMER WAS SWEATING. THE PARAMEDICS GAVE HIM A MANUAL INJECTION TO BRING THE BLOOD GLUCOSE LEVEL UP. CUSTOMER WAS TAKEN TO THE HOSPITAL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346903 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization