BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3243839 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-95999
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 6, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    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. PLEASE SEE MEDWATCH REPORT # 3004209178-2013-95980.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE WAS FLUCTUATING SINCE SHE WAS HOSPITALIZED. THE CALLER WAS UNSURE IF INSULIN HAD LEAKED FROM THE RESERVOIR. HOWEVER, SHE NOTED AIR BUBBLES ON ONE EVENT AFTER THE RESERVOIR HAD BEEN USED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342218 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H8486688

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR