BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4141658 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33231
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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

    CUSTOMER CALLED TO REPORT INSULIN PUMP HAD RESERVOIR LEAKS. THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE AS A RESULT OF THE CRACKED RESERVOIRS. CUSTOMER HAS HAD TO CHANGE THE RESERVOIR THREE TIMES DUE TO THE LEAKING ISSUE. THE CUSTOMER ALSO MENTIONED THAT THE INFUSION SET HAD BEEN PULLED OUT PRIOR TO THE COMPLAINT. THIS CAUSED THE INSULIN PUMP TO ALARM FOR NO DELIVERY. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THAT THE ISSUE HAS BEEN RESOLVED WITH TROUBLESHOOTING. THE CUSTOMER HAD AN APPOINTMENT TO ACQUIRE REPLACEMENT RESERVOIRS. ADVISED THAT THE RESERVOIRS WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621265 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H7576671

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR