BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4141831 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33613
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A NO DELIVERY ALARM ON THE INSULIN PUMP. CUSTOMER STATED THAT SHE WAS EATING DINNER AT HER GRANDDAUGHTER'S BIRTHDAY PARTY AND SHE GOT A NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 159 MG/DL. CUSTOMER WAS ASSISTED IN PERFORMING A 5.0U FIXED PRIME AND STATED THAT THE INSULIN DID EXIT. CUSTOMER DID NOT HAVE ANOTHER INFUSION SET WITH HER. IT WAS EXPLAINED THAT THERE MAY BE A POSSIBLE SITE RELATED ISSUE, POSSIBLY DUE TO A BENT CANNULA OR SITE/SET OCCLUSION. CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET. CUSTOMER WILL CHANGE OUT THE SET WHEN GETS HOME. CUSTOMER WAS ADVISED TO CALL BACK AFTER CHECKING IF THE CANNULA IS BENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621471 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR