BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELT CLIP PUMP CLEAR

    MDR report key: 4211945 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-45364
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 BLOOD GLUCOSE LEVEL OF 400 MG/DL. THE CUSTOMER TREATED HIS HIGH BLOOD GLUCOSE LEVEL WITH HIS INSULIN PUMP AND MANUAL INJECTIONS. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE LEVELS WERE HIGH BECAUSE HE HAD AN EPIDURAL TWO WEEKS AGO. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693827 BELT CLIP PUMP CLEAR CGM MDS MEDTRONIC MINIMED MMT-640CL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other