BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 3893874 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03273
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    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. THE DEVICE WILL BE RETURN FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE PASSED OUT DUE TO HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT SHE WAS TAKEN TO THE EMERGENCY ROOM AND WAS HOSPITALIZED. THE BLOOD GLUCOSE READING WAS HIGH AT THE TIME OF ADMISSION. CUSTOMER STATED THAT SHE HAD A BAD INFECTION AND A RENAL FAILURE PRIOR TO HOSPITALIZATION. CUSTOMER ALSO STATED THAT SHE WAS UNABLE TO FINE HER TRANSMITTER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371751 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization