BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4251721 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52623
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 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. 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. SEE MANUFACTURE REPORT 2032227-2014-52316.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. CUSTOMER STATED THE INSULIN PUMP DELIVERED A LOT OF INSULIN INTO HIS BODY, STARTED TO FEEL LOW AND GOT BUTTON ERROR. CUSTOMER MENTIONED THAT THE INSULIN PUMP HAD SCRATCHED ON THE SCREEN. CUSTOMER'S WIFE DROVE HIM TO EMERGENCY ROOM AND WAS PLACED TO INTENSIVE CARE UNIT RIGHT AWAY. CUSTOMER'S BLOOD GLUCOSE WAS 30 MG/DL. ADVISED THE CUSTOMER THE INSULIN PUMP AND TRANSMITTER WOULD BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738663 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA A000296877

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization