BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 2962330 · Received February 14, 2013

    Report

    Report Number
    2032227-2013-00617
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 26, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2013-00634.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 17 MG/DL. THE CUSTOMER STATED THAT SHE HAS BEEN TAKING STEROIDS AND TREATMENTS FOR OTHER HEALTH ISSUES, WHICH MAY HAVE CONTRIBUTED TO THE LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER ALSO REPORTED THAT SHE LOST HER TRANSMITTER. ADVISED HER THAT A REPLACEMENT WOULD BE SENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65616 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization