BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3083622 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-92871
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    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.

    Description of Event or Problem · 1

    IT IS REPORTED BY DCM, CUSTOMER'S MOTHER STATED THAT RESERVOIR IS LEAKING. CUSTOMER'S BLOOD GLUCOSE READING IS 194 MG/DL. THERE IS INSULIN IN THE RESERVOIR COMPARTMENT. DCM STATED THAT THE CURRENT RESERVOIR HAS A BROKEN PIECES NEAR PCAP AND THE BOTTOM PART OF THE RESERVOIR IS CHIPPED. DCM TO DRY RESERVOIR COMPARTMENT WITH TISSUE, NO COTTON SWAB AVAILABLE. ALL PROGRAMMING IS CORRECT. ADVISED TO MONITOR INSULIN PUMP. MOTHER WANTS INSULIN PUMP REPLACED. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185301 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR