BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK PERSONAL

    MDR report key: 4143430 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30173
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSE 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 IS REPORTED THAT A CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 555 MG/DL. THE CUSTOMER WAS INFORMED THAT THERE COULD BE MANY REASONS FOR HIGH BLOOD GLUCOSE. THE CUSTOMER DECLINED TROUBLE SHOOTING THE INSULIN PUMP AND STATED THAT THEY WERE RUNNING LOW ON RESERVOIRS. THE PATIENT'S BLOOD GLUCOSE WAS 56 MG/DL AT THE TIME OF THE CALL. THE CALLER WAS A FAMILY RELATIVE WHO STATED THEY HAD TROUBLE WITH CARELINK. THE CALL WAS DISCONNECTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603627 CARELINK PERSONAL OYC MEDTRONIC MINIMED MMT-7333

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR