BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 3854945 · Received June 9, 2014

    Report

    Report Number
    2032227-2014-02938
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 12, 2014
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 WAS HOSPITALIZED, DUE TO A HEART ATTACK AND HIGH BLOOD GLUCOSE. CUSTOMER WAS DEHYDRATED. CUSTOMER ALSO STATED SHE LOST HER TRANSMITTER. CUSTOMER TREATED HER HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. THERE WAS NO ISSUE WITH THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 519 MG/DL. THE CURRENT BLOOD GLUCOSE READING IS 143 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336168 MINILINK TRANSMITTER CGM MDS MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization