BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM QUICK SET MMT-396T

    MDR report key: 7176972 · Received January 9, 2018

    Report

    Report Number
    2032227-2018-00539
    Event Type
    Injury
    Date Received
    January 9, 2018
    Date of Event
    December 26, 2017
    Report Date
    January 9, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER WAS ABLE TO TROUBLESHOOT DURING THE CALL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400, 328, 318, 311, 267, 233, 300, 314 AND 205 MG/DL. THE CUSTOMER WAS TREATED WITH AN INJECTION. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA, NOT FILL GOOD. THE CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF LOW BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DOES ALLEGE PUMP WAS OVER DELIVERING. THE CUSTOMER PERFORMED HIGH PRESSURE TEST AND IT DID PASS. THE CUSTOMER ALSO STATES HAD ONE LITTLE SPOT ABOUT 3" FROM THE RESERVOIR, THE SPOT IS ABOUT 1/8" LONG BUBBLE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. CUSTOMER REPORTED DISCONNECTING THE INFUSION SET AT THE QUICK RELEASE. CUSTOMER REPORTED THAT INSULIN EXITED DURING THE FILL TUBING PROCESS. NO PRODUCT IS EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19989 PARADIGM QUICK SET MMT-396T SET, ADMINISTRATION, INTRAVASCULAR FPA MEDTRONIC MINIMED MMT-396T

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other