BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3243693 · Received July 23, 2013

    Report

    Report Number
    2032227-2013-03105
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 29, 2013
    Report Date
    June 29, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THE CALLER WANTED TO KNOW IF A REPRESENTATIVE COULD GO TO THE HOSPITAL TO CHECK THE INSULIN PUMP. ADVISED THE CALLER THAT ALL TROUBLESHOOTING IS DONE OVER THE PHONE WITH THE PRODUCT HELPLINE. THE CALLER STATED THAT SHE WILL HAVE THE CUSTOMER'S FATHER CALL IN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342232 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization