BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3831041 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84932
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 3, 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

    THE CUSTOMER STATED THAT HE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF HIS HOSPITALIZATION WAS 45 MG/DL. PRIOR TO HIS HOSPITALIZATION, THE CUSTOMER WAS WORKING A NIGHT SHIFT. BEFORE HIS SHIFT, THE CUSTOMER STATED THAT HE HAD EATEN LITTLE AND HAD MOSTLY DRUNK WATER IN ORDER TO ACCOMMODATE HIS UNSET BASAL RATES. AFTER THE CUSTOMER GOT HOME, HE PASSED OUT. THE CUSTOMER WAS TAKEN TO THE HOSPITAL. THE CUSTOMER WAS RELEASED ONCE THE BLOOD GLUCOSE WAS STABILIZED. AT THE TIME OF THE CALL, THE CUSTOMER STATED HE DID NOT WANT TO TROUBLESHOOT AND HE ALSO SAID THAT THE INSULIN PUMP WAS FINE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307722 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization