BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML MMT-332A

    MDR report key: 4190553 · Received October 21, 2014

    Report

    Report Number
    3004209178-2014-93627
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. 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 IS REPORTED THAT A CUSTOMER RECEIVED A NO DELIVERY ALARM FROM THEIR INSULIN PUMP DURING BOLUS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS AT 152 MG/DL. THE CUSTOMER WAS HELPED WITH TROUBLE SHOOTING AND IT TURNS OUT THAT THE INSULIN PUMP WORKS PERFECTLY FINE AND THAT THE ISSUES REVOLVED AROUND A USER ERROR. THE CUSTOMER WAS SENT A NEW INFUSION SET. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667313 RESERVOIR 3ML MMT-332A RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG033G9

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR