BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4261510 · Received November 19, 2014

    Report

    Report Number
    2032227-2014-54572
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S RESERVOIR HAD A LEAK. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 248 MG/DL. STANDARD TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S MOTHER STATED THE INSULIN PUMP'S RESERVOIR COMPARTMENT HAD 2 UNITS OF INSULIN IN IT AND THAT THE RESERVOIR'S O-RINGS WERE INTACT. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751647 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H8087009

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR