BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3951371 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88097
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    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 REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE READINGS OF OVER 600 MG/DL. CUSTOMER REPORTED SYMPTOMS OF DIABETES KETOACIDOSIS, DIZZINESS, SHAKINESS AND POUNDING HEART PRIOR TO THE HOSPITALIZATION. CUSTOMER WAS MONITORED FOR THEIR BLOOD GLUCOSE READINGS AND TREATED WITH IV AS WELL AS SHOTS OF INSULIN. CUSTOMER ALSO REPORTED HAVING A BENT CANNULA. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 146 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428950 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization