BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4244035 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50839
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER HAD A DIFFICULT TIME CHANGING THEIR INFUSION SETS. THE CUSTOMER'S WIFE ALSO REPORTED THAT THE INSULIN PUMP ONLY DELIVERED 8 UNITS OF INSULIN INSTEAD OF THE REQUIRED 10 UNITS. THE WIFE WAS ALSO CONCERNED THAT INSULIN DELIVERY DID NOT RESUME AFTER CHANGING HEIR INFUSION SET. THE WIFE WAS ABLE TO RESUME INSULIN DELIVERY AT THE END OF THE CALL. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725872 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR