BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4183549 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40333
    Event Type
    Injury
    Date Received
    October 18, 2014
    Date of Event
    June 7, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 REPORTED A HOSPITALIZATION EVENT ON (B)(6) 2014. BLOOD GLUCOSE AT THE TIME OF ADMISSION WAS OVER 300 MG/DL. THE CUSTOMER STATED THAT SHE HAD GOTTEN A NEW INSULIN PUMP THAT SHE DID NOT PRIME AND AS A RESULT, SHE WAS NOT GETTING ANY INSULIN FOR 24 HOURS. THE CUSTOMER STATED SHE STARTED HAVING SYMPTOMS OF HIGH BLOOD GLUCOSE SUCH AS URINATION AND FEELING LIGHT-HEADED. SHE THEN STATED SHE WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE CUSTOMER ALSO STATED SHE WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663955 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization