BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK PERSONAL

    MDR report key: 4142409 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33785
    Event Type
    Injury
    Date Received
    October 5, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO INQUIRE ABOUT REPLACEMENT INSULIN PUMP. CUSTOMER STATED THAT INSULIN PUMP WAS BEING REPLACED DUE TO UNABLE TO REMOVE THE BATTERY CAP. CUSTOMER REPORTED THAT HER BLOOD GLUCOSE HAD DROPPED TO 48 MG/DL AFTER TREATING FOR A MEAL. CUSTOMER STATED SHE ATE JELLY BEANS TO RAISE SUGAR.CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF CALL WAS AT 178 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621963 CARELINK PERSONAL CGM MDS MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR