BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4170085 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37727
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A NEW PUMP AND SENSOR BUT THE SERTER FELL APART. CUSTOMER STATED THAT HE CAN'T PRESS THE GREEN BUTTON IN AND IT APPEARS THAT THE INSIDE OF THE SERTER IS MISALIGNED. CUSTOMER STATED THAT THE TRANSMITTER MAY HAVE FALLEN OUT OF HIS LUNCH BOX SINCE HE CANNOT FIND IT ANYWHERE. CUSTOMER STATED THAT HE IS VERY PHYSICAL AT WORK AND IT CAUGHT ON A MACHINE AT WORK AND BROKE THE PIN. CUSTOMER DID HAVE A LOW AND WAS TREATED AT THE SCENE BY THE LOCAL EMERGENCY MEDICAL SERVICES, BUT WAS UNSURE OF THE DATE. CUSTOMER STATED THAT HIS FAMILY GETS CONCERNED BECAUSE OF THE ACCIDENT HE HAD IN (B)(6) (CUSTOMER WAS NOT ON THE PUMP AT THE TIME). THE FIRST TIME, THE PUMP DID NOT COME OFF AND THE SECOND TIME, THE PUMP WAS ALREADY SUSPENDED BUT HIS BLOOD GLUCOSE LEVEL DROPPED REALLY FAST. CUSTOMER TREATED WITH GLUCOSE TABLETS AND DRANK JUICE. CUSTOMER WILL BE SENT A REPLACEMENT TRANSMITTER AS A COURTESY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648795 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA A000315690

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR