BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3243689 · Received July 23, 2013

    Report

    Report Number
    2032227-2013-03096
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 SHE WENT TO THE EMERGENCY ROOM DUE TO A HIGH BLOOD GLUCOSE OF 819 MG/DL. THE CUSTOMER STATED THAT SHE HAD BEEN GETTING NO DELIVERY ALARMS DURING THE BASAL RATE DELIVERY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED WITH THE CORRECT TIME AND DATE. THE CUSTOMER DID NOT KNOW IF THE BASAL RATES WERE CORRECT. ADVISED HER TO SPEAK WITH HER HCP REGARDING THE BASAL RATES. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THERE WAS NO TUBING CLAMP FOR THE HIGH PRESSURE TEST. THE CUSTOMER STATED THAT SHE HAS BEEN USING THE SAME INSULIN AND INFUSION SET FOR ABOUT A WEEK, AND THE INSULIN APPEARS TO BE CLOUDY. THE CUSTOMER REMOVED THE INFUSION SET, AND THE CANNULA WAS BENT. ADVISED THE CUSTOMER TO CHANGE THE INFUSION SET, AND TO USE A FRESH VIAL OF INSULIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344103 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization