BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BATTERY CHARGER MLINK

    MDR report key: 3022013 · Received March 26, 2013

    Report

    Report Number
    2032227-2013-01152
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    THE CUSTOMER CALLED TO REPORT THAT HE HAS NOT BEEN ABLE TO USE THE SENSORS FOR A WHILE DUE TO NOT GETTING ANY REACTION WHEN CONNECTING THE TRANSMITTER TO THE SENSOR. THE CUSTOMER ALSO REPORTED THAT THE PARAMEDICS WERE CALLED TO HIS HOME AFTER EXPERIENCING A LOW BLOOD GLUCOSE OF 31 MG/DL. THE CUSTOMER STATED THAT HE FEELS HIS BASAL RATES NEED TO BE ADJUSTED. THE CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE LEVELS, AND STATED HE WANTED TO SPEAK WITH HIS DOCTOR FIRST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123861 BATTERY CHARGER MLINK CGM MDS MEDTRONIC MINIMED MMT-7705NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention