BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 3894850 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03387
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. PLEASE SEE MEDWATCH REPORT # 2032227-2014-03388.

    Description of Event or Problem · 1

    THE REPRESENTATIVE FROM THE PATIENT RELATIONS DEPARTMENT REPORTED THAT THE CUSTOMER WAS ADMITTED TO THE EMERGENCY ROOM. THE CALLER STATED THAT DURING THE TREATMENT THE CUSTOMER'S CONTINUOUS GLUCOSE MONITORING DEVICE WAS REMOVED AND IS NOW MISSING. THE CALLER DID NOT HAVE DETAILS ABOUT THE HOSPITALIZATION AND WAS NOT SURE IF THE EVENT WAS DIABETES RELATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370149 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization