BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4933921 · Received July 22, 2015

    Report

    Report Number
    2032227-2015-23100
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 2, 2015
    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.SEE MANUFACTURE REPORT NUMBER 2032227-2015-23098 FOR SENSOR AND 2032227-2015-23099 FOR THE INSULIN PUMP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE, HE WAS IN THE WATER AND RAFT RUBBED AGAINST SET AND IT PULLED OUT. CUSTOMER THEN ATE THE WRONG THING AFTER THIS AND HER BLOOD GLUCOSE WENT UP TO 800 MG/DL. CUSTOMER WENT HOME CHANGED THE INFUSION SET AND TREATED WITH THE INSULIN PUMP AND WENT TO BED. CUSTOMER STATED THE TRANSMITTER WAS LEFT IN THE HOT DAY AND NOW IT WASN'T WORKING. CUSTOMER IS NOT RETURNING THE DEVICE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474334 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other